Risk Information

NANOKNIFE

Important Risk Information

INDICATION FOR USE:

 

US: The NanoKnife System is intended  for surgical ablation of soft tissue. The system includes an energy generator, footswitch and single-use disposable electrodes. The NanoKnife System has not been approved for therapy or treatment of any specific disease state or condition.

 

CE: The NanoKnife System is a medical device for cell membrane electroporation. Electroporation is a phenomenon that occurs in cell membranes as cells are exposed to an electrical field of sufficiently high intensity. The electric field acts as a physical stimulus, bringing about alterations in cell membranes that result in increased permeability.

 

CONTRAINDICATIONS: Ablation procedures using the NanoKnife System are contraindicated in the following cases: ablation of lesions in the thoracic area in the presence of implanted cardiac pacemakers or defibrillators; ablation of lesions in the vicinity of implanted electronic devices or implanted devices with metal parts; ablation of lesions of the eyes, including the eyelids; or patients with a history of Epilepsy, cardiac arrhythmia, or recent history of myocardial infarction.
 

WARNINGS AND PRECAUTIONS: For single use only. Avoid short-circuiting the electrodes when delivering pulses. An electrocution hazard exists. The Generator internally produces voltages that are dangerous and may be fatal.  An arrhythmia risk exists. Ensure that interventions (defibrillator, etc.) and appropriately trained personnel are readily available for dealing with cardiac arrhythmias. Do not use the Generator in the presence of flammable or explosive gas mixtures. Do not use the Generator if a malfunction is suspected. The physician MUST read the User Manual thoroughly before operating the NanoKnife System. The effects of NanoKnife System use on a fetus are not known. Procedure on pregnant women should be contemplated only after ensuring that the procedure benefits outweigh the risks.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


Solero

Important Risk Information

INDICATION FOR USE:

 

CE: The Solero Microwave Tissue Ablation (MTA) System and Accessories are indicated for the ablation of soft tissue during open, laparoscopic, or percutaneous procedures. The Solero MTA System is not intended for cardiac use.

 

US: The Solero Microwave Tissue Ablation (MTA) System and Accessories are indicated for the ablation of soft tissue during open procedures. The Solero MTA System is not indicated for cardiac use.

 

Please refer to the Solero Generator Operator’s Manual and the Solero Applicator Directions For Use for complete instructions, warnings, and precautions.


STARBURST XL

Important Risk Information
INDICATION FOR USE: The StarBurst XL Electrosurgical Device is a tool to transmit monopolar radiofrequency energy (provided by the Model 1500X RF Generator) and is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue including the partial or complete ablation of non-resectable liver lesions and palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy.

 

CONTRAINDICATIONS: None known.

 

WARNINGS AND PRECAUTIONS: For single use only. Do not bend or kink the trocar or the needles or exert forceful pressure on Device while it is deployed in the tissue; do not attach anything (i.e., clamps, etc.) to the Device, or use metal introducers that do not have insulation; inadvertent patient injury may result. To ensure safe and effective use follow the manufacturer’s directions and recommended practices for the preparation, placement, surveillance, removal and use of the dispersive electrode. To achieve the desired ablation follow the manufacturer’s guidelines of ablation time and temperature. Ensure that the device is placed at least 1 cm away from structures not intended for ablation. In laparoscopic procedures, care must be taken to avoid a gas embolism, and activation of the device when not in contact with target tissue may cause capacitive coupling. In some cases, a liver lesion will only be partially destroyed; the final determination of the success of lesion destruction can only be made by imaging studies following the procedure and during regular long-term follow-up. For ablation of painful bone metastases, do not perform RF ablation in weight-bearing bone with evidence of impending fracture. Pathologic fracture is more prevalent and serious in long bone. Please see package insert for complete list of warnings and precautions.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.  


STARBURST XLI

Important Risk Information
INDICATION FOR USE: The StarBurst Xli-enhanced Electrosurgical Device is a tool to transmit monopolar radiofrequency energy (provided by the Model 1500X RF Generator). It is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue including the partial or complete ablation of non-resectable liver lesions and palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy.  

 

CONTRAINDICATIONS: None known.

 

WARNINGS AND PRECAUTIONS: For single use only. Do not bend or kink the trocar or the needles or exert forceful pressure on Device while it is deployed in the tissue; do not attach anything (i.e., clamps, etc.) to the Device, or use metal introducers that do not have insulation; inadvertent patient injury may result. To ensure safe and effective use follow the manufacturer’s directions and recommended practices for the preparation, placement, surveillance, removal and use of the dispersive electrode. To achieve the desired ablation follow the manufacturer’s guidelines of ablation time and temperature. Ensure that the device is placed at least 1 cm away from structures not intended for ablation. In laparoscopic procedures, care must be taken to avoid a gas embolism, and activation of the device when not in contact with target tissue may cause capacitive coupling. In some cases, a liver lesion will only be partially destroyed; the final determination of the success of lesion destruction can only be made by imaging studies following the procedure and during regular long-term follow-up. For ablation of painful bone metastases, do not perform RF ablation in weight-bearing bone with evidence of impending fracture. Pathologic fracture is more prevalent and serious in long bone. Please see package insert for complete list of warnings and precautions.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications.  Observe all instructions for use prior to use.  Failure to do so may result in patient complications.


STARBURST MRI and SDE

Important Risk Information
INDICATION FOR USE: The StarBurst MRI and SDE Electrosurgical Devices transmit monopolar radiofrequency energy (provided by the Model 1500X RF Generator) and are indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue including the partial or complete ablation of non-resectable liver lesions and palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard pain therapy.

 

CONTRAINDICATIONS: None known.

 

WARNINGS AND PRECAUTIONS: For single use only. Do not bend or kink the trocar or the needles or exert forceful pressure on Device while it is deployed in the tissue; do not attach anything (i.e., clamps, etc.) to the Device, or use metal introducers that do not have insulation; inadvertent patient injury may result. To ensure safe and effective use follow the manufacturer’s directions and recommended practices for the preparation, placement, surveillance, removal and use of the dispersive electrode. To achieve the desired ablation follow the manufacturer’s guidelines of ablation time and temperature. Ensure that the device is placed at least 1 cm away from structures not intended for ablation. In laparoscopic procedures, care must be taken to avoid a gas embolism, and activation of the device when not in contact with target tissue may cause capacitive coupling. In some cases, a liver lesion will only be partially destroyed; the final determination of the success of lesion destruction can only be made by imaging studies following the procedure and during regular long-term follow-up. For ablation of painful bone metastases, do not perform RF ablation in weight-bearing bone with evidence of impending fracture. Pathologic fracture is more prevalent and serious in long bone. Please see package insert for complete list of warnings and precautions.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.  


STARBURST TALON

Important Risk Information
INDICATION FOR USE: The StarBurst Talon Electrosurgical Device is a tool to transmit monopolar radiofrequency energy (provided by the Model 1500X RF Generator) in conjunction with the IntelliFlow Infusion pump. It is indicated for use in percutaneous, laparoscopic, or intraoperative coagulation and ablation of soft tissue. 

 

CONTRAINDICATIONS: None known.

 

WARNINGS AND PRECAUTIONS: For single use only. Do not bend or kink the trocar or the needles or exert forceful pressure on Device while it is deployed in the tissue; do not attach anything (i.e., clamps, etc.) to the Device, or use metal introducers that do not have insulation; inadvertent patient injury may result. To ensure safe and effective use follow the manufacturer’s directions and recommended practices for the preparation, placement, surveillance, removal and use of the dispersive electrode. To achieve the desired ablation follow the manufacturer’s guidelines of ablation time and temperature. Ensure that the device is placed at least 1 cm away from structures not intended for ablation. In laparoscopic procedures, care must be taken to avoid a gas embolism, and activation of the device when not in contact with target tissue may cause capacitive coupling. In some cases, a liver lesion will only be partially destroyed; the final determination of the success of lesion destruction can only be made by imaging studies following the procedure and during regular long-term follow-up. For ablation of painful bone metastases, do not perform RF ablation in weight-bearing bone with evidence of impending fracture. Pathologic fracture is more prevalent and serious in long bone. Please see package insert for complete list of warnings and precautions.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications. 


HABIB 4X

Important Risk Information
INDICATION FOR USE:
The Habib 4X device is used to transmit radiofrequency energy provided by the 1500X RF Generator.  It is intended to be used in intraoperative coagulation of tissue during surgical procedures. The Habib 4X Laparoscopic device is used to transmit radiofrequency energy provided by the 1500X RF Generator.  It is intended to be used in intraoperative coagulation of tissue during surgical procedures.  The Habib device is used to develop a plane of coagulative necrosis along the intended line of transection. The tissue can subsequently be divided with a conventional scalpel through this zone of necrosis.

 

CONTRAINDICATIONS: Do not use on patients with cardiac pacemakers or other active implants.

 

WARNINGS AND PRECAUTIONS: For single use only. Do not bend/kink the needle arrays or attach anything (i.e., clamps, etc.) to the device; inadvertent patient injury may result. Do not use needle-monitoring or dispersive electrodes. This device may interfere with the operation of other electronic equipment. Improper placement or handling of bipolar electrodes while RF is on may lead to burns. Please see package insert for complete list of warnings and precautions and observe all instructions prior to use.

 

Refer to individual product IFUs and/or User Manual to see full Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


VenaCure 1470nm Laser

Important Risk Information
INDICATION FOR USE:
The AngioDynamics, VenaCure 1470 laser is indicated for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb.

 

CONTRAINDICATIONS: Patients should not have their varicosities ablated who have the following conditions: thrombus in the vein segment to be treated; an inability to ambulate; severe arterial disease; deep vein thrombosis or those with a history of DVT’s; pregnant or breast-feeding; or patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment.

 

WARNINGS AND PRECAUTIONS: Read the Instructions For Use and the Laser Operator’s manual thoroughly prior to using VenaCure EVLT procedure kits. Observe all warnings, precautions and cautions noted. Failure to do so may result in patient complications.

 

CAUTION: Intended for use only by fully trained physicians. Federal (USA) law restricts these devices to sale by or on the order of a physician. VenaCure EVLT procedure kits are intended for single patient use only. Inspect the sealed packages before opening. If seals are broken or the packages are damaged, treat as non-sterile and discard. Ensure expiration dates on the VenaCure EVLT procedure kits are still valid. Laser protective eyewear must be worn by everyone in the treatment room, including the patient. Treatment of a vein located close to the skin surface may result in a skin burn.

 

POTENTIAL COMPLICATIONS: Adverse reactions may include, but are not limited to: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthesia due to thermal damage of adjacent sensory nerves, skin burns, and thrombophlebitis.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


NeverTouch Procedure Kit

Important Risk Information
INDICATION FOR USE: The AngioDynamics, Inc. VenaCure EVLT NeverTouch - FRS Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.

 

EXCLUSIONS: Patients with thrombus in the vein segment to be treated. Patients with an aneurysmal section in the vein segment to be treated. Patients with peripheral artery disease as determined by an Ankle- Brachial Index <0.9.

 

SAFETY PRECAUTION: All persons in the treatment room must be wearing protective glasses with the proper rating for the wavelength being used.

 

POTENTIAL COMPLICATIONS: The potential complications include but are not limited to the following: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin pigmentation alteration, neovascularization, paresthesia due to thermal damage of adjacent sensory nerves, anesthetic tumescence, non-target irradiation, vasospasm, hemorrhage, necrosis, skin burns and pain.

 

WARNINGS: Treatment of a vein located close to the skin surface may result in skin burn. Paresthesia may occur from thermal damage to adjacent sensory nerves. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy with appropriate eye and protective wear for both patient and operating personnel. Do not re-use the fibers or re-sterilize the fibers.

 

PRECAUTIONS: Prior to and during use, avoid damaging the fiber by striking, stressing, or excessive bending of the fiber. Do not coil the fiber tighter than a diameter of 20 cm. Clinical safety and effectiveness data is not available for other fiber tip designs and diameters. Prior to and during use, avoid bending the introducer sheath and dilator as this can cause kinks and damage.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


NeverTouch Direct Procedure Kit

Important Risk Information
INDICATION FOR USE: The AngioDynamics, Inc. VenaCure EVLT NeverTouch Direct Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. This product should be used only with lasers cleared for use in the treatment of varicose veins, varicosities with superficial reflux of the GSV, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limbs.

 

EXCLUSIONS: Patients with thrombus in the vein segment to be treated, patients with an aneurysmal section in the vein segment to be treated or patients with peripheral artery disease as determined by the Ankle Brachial Pressure Index with a value of <0.9 should not have their varicosities ablated.

 

WARNINGS AND PRECAUTIONS: Treatment of a vein located close to the skin surface may result in skin burn. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy. All persons in the treatment room MUST wear protective glasses with the proper rating for the wavelength being used.

 

CAUTION: This device is ethylene oxide sterilized and intended for single patient use only. Do not reuse or resterilize the fibers. Contents sterile in unopened, undamaged package. Do not use if opened or any sign of product damage is visible. Carefully read all directions and observe all Warnings and Precautions prior to performing the procedure.

 

POTENTIAL COMPLICATIONS: Adverse reactions may include, but are not limited to: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, skin pigmentation alteration, neovascularization, paresthesia due to thermal damage of adjacent sensory nerves, anesthetic tumescence, non-target irradiation, vasospasm, hemorrhage, necrosis, skin burns and pain. Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.

 

CAUTION: Federal (USA) law restricts the sale of this device by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


400um Fiber Procedure Kit

Important Risk Information
INDICATION FOR USE:
AngioDynamics Laser and VenaCure EVLT Procedure Kits with the 400 μm Fiber are indicated for use in the treatment of varicose veins and varicosities associated with superficial vein reflux of the great saphenous vein, and with veins in the lower limbs with superficial reflux. The D15 Plus, D30 Plus, Delta-15 and Delta-30 lasers and VenaCure EVLT Kits are indicated for treatment of incompetent refluxing veins in the superficial venous system.

 

CONTRAINDICATIONS: Patients should not have their varicosities ablated who have the following conditions: thrombus in the vein segment to be treated; aneurysmal section in the vein segment to be treated; peripheral artery disease as determined by Ankle Brachial Pressure Index with a value of <0.9; an inability to ambulate; deep vein thrombosis; pregnant or breast-feeding; or patients in general poor health. Other contraindications may be raised by the individual physician at the time of treatment.

 

WARNINGS AND PRECAUTIONS: Read the Instructions For Use and the Laser Operator’s manual thoroughly prior to using the VenaCure EVLT Procedure Kits with the 400 μm Fiber. Observe all warnings, precautions and cautions noted. Failure to do so may result in patient complications. Laser protective eyewear must be worn by everyone in the treatment room, including the patient.

 

CAUTION: Intended for use only by fully trained physicians. Federal (USA) law restricts these devices to sale by or on the order of a physician. The VenaCure EVLT Procedure Kit is intended for single patient use only. Inspect the sealed packages before opening. If seals are broken or the packages are damaged, treat as non-sterile and discard. Ensure expiration dates are still valid. Treatment of a vein located close to the skin surface may result in a skin burn. Tissue not targeted for treatment must be protected from injury by direct and reflected laser energy.

 

POTENTIAL COMPLICATIONS: Adverse reactions may include, but are not limited to: vessel perforation, thrombosis, pulmonary embolism, phlebitis, hematoma, infection, paresthesia due to thermal damage of adjacent sensory nerves, skin burns, and thrombophlebitis. Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


IMPLANTABLE PORTS

Important Risk Information
INDICATION FOR USE:
AngioDynamics implantable access port systems are intended to facilitate frequent blood sampling or the delivery of medications, nutritions, blood products, and imaging solutions.

 

CONTRAINDICATIONS: AngioDynamics port systems should not be implanted in the presence of known or suspected infections, septicemia, or peritonitis, in patients who have exhibited prior intolerance to the materials of construction, or patients whose body size or tissue is insufficient to accommodate the size of the port or catheter.  CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

 

WARNINGS AND PRECAUTIONS: The device is sterile and intended for single patient use. Sterile unless the package is opened or damaged. Do not re-sterilize. Use of AngioDynamics anti-coring (19 to 22 gauge Huber point) needles in all procedures is recommended. Observe all instructions for use. Failure to do so may result in patient complications or device damage. 

 

POTENTIAL COMPLICATIONS: Use of port systems involve potential risks normally associated with the insertion or use of any implanted device or indwelling catheter including but not limited to: Infection; pneumothorax; catheter malposition, migration or fragmentation; catheter pinch-off or rejection; hemorrhage; hematoma; clot formation, thrombophlebitis or thromboembolism; vessel trauma, including puncture, laceration, and erosion of vessel and skin; cardiac arrhythmia, puncture and tamponade; endocarditis; thoracic duct injury; peritonitis; fibrin sheath; and drug extravasation (leakage). Occlusion may result from clot formation inside the lumen of the catheter, precipitate formation inside the port from incompatible drugs, or from catheter tip placement against a vein wall or valve.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


SMART PORT

The following is a brief summary of important risk information for the Smart Port power-injectable port line. For detailed information on the categories referenced, please consult the instructions for use packaged with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.

 

INDICATION FOR USE: The Smart Port CT power injectable port line is indicated for any patient requiring repeated access of the vasculature system, for delivery of medications, nutritional supplementation, fluids, blood, blood products, sampling of blood and power injection of contrast media for imaging.  MINI AND LP MODELS: When used with non Y site LifeGuard Safety Infusion sets in 20Ga or 19Ga size, the SmartPort CT Access System is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 ml/sec. 

 

CONTRAINDICATIONS: Smart Port CT should not be implanted in the presence of known or suspected infections, bacteremia, septicemia and peritonitis, or in patients who have exhibited prior intolerance to the materials of construction, or patients whose body size or tissue is insufficient to accommodate the size of the port or catheter.

 

WARNINGS AND PRECAUTIONS: Please see package insert for complete list of warnings and precautions.

 

POTENTIAL COMPLICATIONS: Consult package insert for a complete list of potential complications.

 

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


MORPHEUS

Important Risk Information
INDICATIONS FOR USE:
The AngioDynamics Morpheus SMART PICC CT is indicated for short or long term peripheral access to the central venous system for intravenous therapy, power injections of contrast media, and allows for central venous pressure monitoring. For blood sampling, infusion, or therapy use a 4 French or larger catheter. For central venous pressure monitoring, it is recommended that a catheter lumen of 20 gauge or larger be used.

 

CONTRAINDICATIONS: This device is contraindicated whenever the patient has or is suspected of having: infection, bacteremia, or septicemia; allergic reactions to the device’s materials; insufficient body size to accommodate the size of the implanted device; past irradiation; previous episodes of venous thrombosis or vascular surgical procedures at the prospective placement site; local tissue factors will prevent proper device stabilization and/or access.

 

WARNINGS AND PRECAUTIONS: Please see package insert for complete list of warnings and precautions.

 

POTENTIAL COMPLICATIONS: Please see package insert for complete list of potential complications. Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.

 

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician


XCELA

XCELA PICC WITH PASV Valve technology

Important Risk Information
INTENDED USE/INDICATIONS FOR USE: The Xcela PICC with PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

 

CONTRAINDICATIONS: Venous thrombosis in any portion of the vein to be catheterized. Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy. Orthopedic or neurological conditions affecting the extremity. Anticipation or presence of dialysis grafts or other intraluminal devices. Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy. Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site. Anatomical distortion of the veins from surgery, injury or trauma. Inadequate antecubital veins. Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures. Patients with known allergies to tape or adhesive.

 

WARNINGS: Due to the risk of exposure to bloodborne pathogens, care providers must adhere to guidelines for universal blood and bodily fluid precautions in the care of all patients. Sterile technique must be strictly adhered to during any handling of the device. Contents are supplied sterile by EO for single patient use only. Do not use if sterile barrier is damaged. Do not use if product has been damaged. Do not reuse, reprocess or resterilize, to do so may compromise device integrity and/or lead to device failure which in turn may result in patient injury, illness or death; and may also create a risk of contamination, patient infection or cross infection which may lead to injury, illness or death of the patient. Do not place the catheter into the right atrium or the right ventricle of the heart. Do not attempt to trim the catheter with the guidewire or stylet loaded as catheter, stylet, or guidewire may become damaged resulting in patient injury. Failure to warm contrast media to body temperature prior to power injection may result in catheter failure. Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure. Power injector’s pressure limiting (safety cut-off) feature may not prevent over-pressurization of occluded catheter. Exceeding the maximum allowable flow rate (per the Directions for Use) may result in catheter failure and/or catheter tip displacement. Catheter indication for power injection of contrast media implies the catheter’s ability to withstand this procedure, but does not imply appropriateness of this procedure for a particular patient. A trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure. The maximum pressure of power injectors used with the Xcela PICC with PASV Valve Technology must not exceed 325 psi. Exceeding maximum allowable flow rate may result in catheter failure and/or catheter tip displacement. For triple lumen catheters, only the purple lumen is for power injection. Do not use lumen marked “No CT” for power injection of contrast media as it may result in catheter damage or patient injury

 

PRECAUTIONS: Do not insert the stiff end of the floppy-tipped guidewire into the vein. Acetone and polyethylene glycol-containing ointments should not be used with polyurethane catheters, as these may cause failure of the device. Following institutional policy, secure catheter externally to prevent catheter movement, migration, damage, kinking or occlusion. It is recommended that institutional protocols be considered for all aspects of catheter use consistent with the instructions provided herein including flushing of occluded catheters and power injection. The Xcela PICC with PASV Valve Technology catheter testing included 10 power injection cycles. Use of a needle to access the catheter is not recommended. However, if a needle is used, do not use a needle longer than 1.9 cm as it may cause damage to the valve. Do not reinsert stylet into catheter, as damage to valve, catheter and vein may result. If a needleless connector is attached to catheter hub, first ensure that it will sustain power injection. When inserting a triple lumen catheter, the power injectable lumen must be used for guidewire/stylet placement.

 

Refer to Directions for Use provided with the product for complete instructions, warnings and precautions.

 

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


BIOFLO PICC

Important Risk Information
INTENDED USE/INDICATIONS FOR USE:
The BioFlo PICC with Endexo and PASV Valve Technology is indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media.

 

CONTRAINDICATIONS: Venous thrombosis in any portion of the vein to be catheterized. Conditions that impede venous return from the extremity such as paralysis or lymphedema after mastectomy. Orthopedic or neurological conditions affecting the extremity. Anticipation or presence of dialysis grafts or other intraluminal devices. Hypercoagulopathy unless considerations are made to place the patient on anticoagulation therapy. Pre-existing skin surface or subsurface infection at or near the proposed catheter insertion site. Anatomical distortion of the veins from surgery, injury or trauma. Inadequate antecubital veins. Anatomical irregularities (structural or vascular) which may compromise catheter insertion or catheter care procedures. Patients with known allergies to tape or adhesive.

 

WARNINGS: Due to the risk of exposure to bloodborne pathogens, care providers must adhere to guidelines for universal blood and bodily fluid precautions in the care of all patients. Sterile technique must be strictly adhered to during any handling of the device. Contents are supplied sterile by EO for single patient use only. Do not use if sterile barrier is damaged. Do not use if product has been damaged. Do not reuse, reprocess or resterilize, to do so may compromise device integrity and/or lead to device failure which in turn may result in patient injury, illness or death; and may also create a risk of contamination, patient infection or cross infection which may lead to injury, illness or death of the patient. Do not place the catheter into the right atrium or the right ventricle of the heart. Do not attempt to trim the catheter with the guidewire or stylet loaded as catheter, stylet, or guidewire may become damaged resulting in patient injury. Failure to warm contrast media to body temperature prior to power injection may result in catheter failure. Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure. Power injector’s pressure limiting (safety cut-off) feature may not prevent over-pressurization of occluded catheter. Exceeding the maximum allowable flow rate (per the Directions for Use) may result in catheter failure and/or catheter tip displacement. Catheter indication for power injection of contrast media implies the catheter’s ability to withstand this procedure, but does not imply appropriateness of this procedure for a particular patient. A trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure. The maximum pressure of power injectors used with the BioFlo PICC must not exceed 325 psi. For triple lumen catheters, only the purple lumen is for power injection. Do not use lumen marked “No CT” for power injection of contrast media as it may result in catheter damage or patient injury.

 

PRECAUTIONS: Do not insert the stiff end of the floppy-tipped guidewire into the vein. Acetone and polyethylene glycol-containing ointments should not be used with polyurethane catheters, as these may cause failure of the device. Following institutional policy, secure catheter externally to prevent catheter movement, migration, damage, kinking or occlusion. It is recommended that institutional protocols be considered for all aspects of catheter use consistent with the instructions provided herein including flushing of occluded catheters and power injection. The BioFlo PICC catheter testing included 10 power injection cycles. Use of a needle to access the catheter is not recommended. However, if a needle is used, do not use a needle longer than 1.9 cm as it may cause damage to the valve. Do not reinsert stylet into catheter, as damage to valve, catheter and vein may result. If a needleless connector is attached to catheter hub, first ensure that it will sustain power injection. When inserting a triple lumen catheter, the power injectable lumen must be used for guidewire/stylet placement. Refer to Directions for Use provided with the product for complete instructions, warnings and precautions.

 

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


DURAMAX

Important Risk Information
INDICATIONS FOR USE: The DuraMax Hemodialysis Catheter is indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include subclavian vein as required. Catheters greater than 40 cm are intended for femoral vein insertion. This catheter is indicated for > 30 days long term placement. The Valved Peelable Introducer is intended for use in the percutaneous insertion of catheters in the venous system.

 

CONTRAINDICATIONS: The catheter is intended for Long-Term vascular access only and should not be used for any purpose other than indicated in these instructions. The valved peelable introducer sheath is not designed for use in the arterial system.

 

WARNINGS AND PRECAUTIONS: Please see package insert for complete list of warnings and precautions.

 

POTENTIAL COMPLICATIONS: Consult package insert for a complete list of potential complications. Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


SCHON

Important Risk Information
INDICATION FOR USE: The AngioDynamics Schon Hemodialysis Catheter is designed for use in attaining long-term vascular access for hemodialysis and apheresis. It may be inserted percutaneously and is primarily placed in the internal jugular vein of an adult patient. Alternate insertion sites include subclavian vein as required. CAUTION: Federal (USA) law restricts these devices to
sale by or on the order of a physician.

 

CONTRAINDICATIONS: This catheter should not be used for any purpose other than those indicated in the instructions. Do not implant catheter in thrombosed vessels.

 

WARNINGS AND PRECAUTIONS: For single use only. Do not reuse, reprocess or resterilize the catheter. Contents sterile and non-pyrogenic in unopened, undamaged package. Do not use if opened or any sign of product damage is visible. Do not use alcohol or acetone based solutions on this catheter; failure of catheter will result. Iodine-based solutions are recommended as the antiseptic solution that can be used on this catheter. Use only Luer Lock (threaded) connectors with this catheter. In the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter. Immediately after insertion, confirm proper placement of the tip of the catheter with x-ray. Failure to verify catheter placement may result in serious trauma or fatal complications. Please see package insert for complete list of warnings and precautions.

 

POTENTIAL COMPLICATIONS: Procedure-related complications include: air embolus; bacteremia; brachial plexus, mediastinal or pleural injury; cardiac arrhythmia or tamponade; central venous, lumen or vascular thrombosis; endocarditis; exit-site or tunnel infection; exsanguination; hematoma; hemorrhage; hemothorax or pneumothorax; laceration/perforation of the vessel or thoracic duct; punctures (right atrial, subclavian artery, superior vena cava); retroperitoneal bleed and septicemia.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


UNI*FUSE

Important Risk Information
INDICATION FOR USE: AngioDynamics UNI*FUSE Infusion System is intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

 

CONTRAINDICATIONS: The UNI*FUSE Infusion System is contraindicated for use in the coronary vasculature and is not for the infusion of blood or blood products. WARNINGS AND PRECAUTIONS: The UNI*FUSE Infusion System is sterile and intended for single patient use and use only by fully trained physicians in angiography and percutaneous interventional procedures. Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient. Do not inject contrast medium with a pressure injector if the occluding ball wire is in place. Use an introducer sheath if the puncture is through a synthetic graft. Failure to use an introducer sheath may result in damage to the catheter.

 

POTENTIAL COMPLICATIONS: Adverse reactions may include, but are not limited to: vessel perforation, dissection, hematoma, stroke, hemorrhage, contrast extravasation, embolism/thrombus, vaso spasm, drug reaction, neurological deficits, and pain and tenderness. Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each device. Observe all instructions prior to use. Failure to do so may result in patient complications.

 

CAUTION: Federal (USA) law restricts the sale of these devices by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


Pulse*Spray

Important Risk Information
INDICATION FOR USE: AngioDynamics PULSE*SPRAY System, PRO Infusion Catheter, and its related components, are intended for the administration of fluids, including thrombolytic agents and contrast media, into the peripheral vasculature.

 

CONTRAINDICATIONS: The PULSE*SPRAY System is contraindicated for use in the coronary vasculature and is not intended for the infusion of blood or blood products.

 

WARNINGS AND PRECAUTIONS: The PULSE*SPRAY System, PRO Infusion Catheter, and its related components are supplied sterile and are intended for single-use only. Do not reuse or resterilize these devices. This System should be used only by physicians who have a thorough understanding of angiography and percutaneous interventional procedures. Do not substitute a component from another manufacturer. Do not inject contrast with power injector, if Occluding Guidewire or Occluding Ball Wire is in place. The use of an introducer sheath is recommended if puncture through a synthetic graft is necessary. Refer to the product insert of the therapeutic solution for indications, contraindications, side effects and precautions.

POTENTIAL COMPLICATIONS: Adverse complications may include, but are not limited to: hematoma at the entry site, pain and tenderness, vessel dissection or perforation, vasospasm, hemorrhage, embolism, contrast extravasation, drug reaction, allergic reaction to contrast media, neurological deficits including stroke and death, and vascular thrombosis.

 

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the instructions for use supplied with each guidewire. Observe all instructions prior to use. Failure to do so may result in patient complications or death.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


SOFT-VU

Important Risk Information
INDICATION FOR USE: AngioDynamics Angiographic Catheters are designed for use where angiographic diagnosis is indicated.

 

CONTRAINDICATIONS: Angiographic Catheters should not be used for any purpose other than those indicated in the instructions.

 

WARNINGS AND PRECAUTIONS: This device is sterilized by ethylene oxide and is intended for single patient use only. Do not reuse or resterilize. Contents sterile in unopened, undamaged package. Do not use if opened or any sign of product damage is visible. AngioDynamics Angiographic Catheters should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures. Do not insert catheters directly through synthetic vascular grafts. Insert through a sheath introducer. AngioDynamics Angiographic Catheters are designed for use with specific guidewire diameters. The recommended maximum guidewire diameter is specified on the catheter label. Optimal guidewire size and judicious use are recommended. Please see package insert for complete list of warnings and precautions.

 

POTENTIAL COMPLICATIONS: The following adverse reactions have been reported and are associated with the use of angiographic catheters: Thrombus formation, emboli, arterial wall damage, plaque dislodgment, hematoma, cardiac arrhythmias, myocardial infarction, stroke, and death.

 

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


ACCU-VU

Important Risk Information
INDICATION FOR USE: AngioDynamics Angiographic Catheters are designed for use where angiographic diagnosis is indicated.

 

CONTRAINDICATIONS: Angiographic Catheters should not be used for any purpose other than those indicated in the instructions.

 

WARNINGS AND PRECAUTIONS: This device is sterilized by ethylene oxide and is intended for single patient use only. Do not reuse or resterilize. Contents sterile in unopened, undamaged package. Do not use if opened or any sign of product damage is visible. AngioDynamics Angiographic Catheters should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures. Do not insert catheters directly through synthetic vascular grafts. Insert through a sheath introducer. AngioDynamics Angiographic Catheters are designed for use with specific guidewire diameters. The recommended maximum guidewire diameter is specified on the catheter label. Optimal guidewire size and judicious use are recommended. Please see package insert for complete list of warnings and precautions.

 

POTENTIAL COMPLICATIONS: The following adverse reactions have been reported and are associated with the use of angiographic catheters: Thrombus formation, emboli, arterial wall damage, plaque dislodgment, hematoma, cardiac arrhythmias, myocardial infarction, stroke, and death.

 

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


MARINER

Imporant Risk Information
INDICATION FOR USE: AngioDynamics Angiographic Catheters are designed for use where angiographic diagnosis is indicated.

 

CONTRAINDICATIONS: Angiographic Catheters should not be used for any purpose other than those indicated in the instructions.

 

WARNINGS AND PRECAUTIONS: This device is sterilized by ethylene oxide and is intended for single patient use only. Do not reuse or resterilize. Contents sterile in unopened, undamaged package. Do not use if opened or any sign of product damage is visible. AngioDynamics Angiographic Catheters should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures. Do not insert catheters directly through synthetic vascular grafts. Insert through a sheath introducer. AngioDynamics Angiographic Catheters are designed for use with specific guidewire diameters. The recommended maximum guidewire diameter is specified on the catheter label. Optimal guidewire size and judicious use are recommended. Please see package insert for complete list of warnings and precautions.

 

POTENTIAL COMPLICATIONS: The following adverse reactions have been reported and are associated with the use of angiographic catheters: Thrombus formation, emboli, arterial wall damage, plaque dislodgment, hematoma, cardiac arrhythmias, myocardial infarction, stroke, and death.

 

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


ANGIOPTIC

Important Risk Information
INDICATION FOR USE: AngioDynamics Angiographic Catheters are designed for use where angiographic diagnosis is indicated.

 

CONTRAINDICATIONS: Angiographic Catheters should not be used for any purpose other than those indicated in the instructions.

 

WARNINGS AND PRECAUTIONS: This device is sterilized by ethylene oxide and is intended for single patient use only. Do not reuse or resterilize. Contents sterile in unopened, undamaged package. Do not use if opened or any sign of product damage is visible. AngioDynamics Angiographic Catheters should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures. AngioDynamics 3 French Angiographic Catheters are not intended for intracranial use. Do not insert catheters directly through synthetic vascular grafts. Insert through a sheath introducer. AngioDynamics Angiographic Catheters are designed for use with specific guidewire diameters. The recommended maximum guidewire diameter is specified on the catheter label. Optimal guidewire size and judicious use are recommended. Please see package insert for complete list of warnings and precautions.

 

POTENTIAL COMPLICATIONS: The following adverse reactions have been reported and are associated with the use of angiographic catheters: Thrombus formation, emboli, arterial wall damage, plaque dislodgment, hematoma, cardiac arrhythmias, myocardial infarction, stroke, and death.

 

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


TOTAL ABSCESSION

Important Risk Information
General Drain: INDICATIONS FOR USE: The General Drainage Catheters are designed for percutaneous drainage of fluids. This device is not indicated for direct contact with the heart, central circulatory system or the central nervous system. WARNINGS: Do not use this catheter with alcohol. Do not use this catheter as a delivery system for nutritional supplements. POTENTIAL ADVERSE EFFECTS: The following adverse reactions have been reported with the use of drainage catheters: biocompatibility reaction, hemorrhage, sepsis, pneumothorax, pyopneumothorax, empyema, bronchopleural fistula, loculation, skin infection, catheter occlusion, and catheter dislodgment

 

Biliary Drain: INDICATIONS FOR USE: The Biliary Drainage catheters are intended for percutaneous transhepatic biliary drainage. WARNINGS: Do not use this catheter with alcohol. Placing a 10 French or larger catheter as the primary drain before formation of a tract may be difficult in some patients. In these patients, the initial biliary drainage should be started with a smaller (8 French) catheter until a suitable tract allows placement of a larger catheter. POTENTIAL ADVERSE EFFECTS: The following adverse reactions have been reported with the use of biliary drainage catheters: hemorrhage, sepsis, pneumothorax, skin infection, catheter occlusion, catheter dislodgment, biloma, bile peritonitis, and perforation of the bile ducts, liver and/or duodenum

 

Nephrostomy Drain: INDICATION FOR USE: The Nephrostomy Drainage catheters are designed for percutaneous drainage of the kidneys. WARNINGS: Do not use this catheter with alcohol. Do not use this catheter as a delivery system for nutritional supplements. POTENTIAL ADVERSE EFFECTS: The following adverse reactions have been reported with the use of nephrostomy drainage catheters: biocompatibility reaction, hemorrhage, sepsis, empyema, skin infection, catheter occlusion, and catheter dislodgment.

 

CAUTION: This device is sterilized by ethylene oxide. The device is sterile and intended for single patient use. Sterile unless the package is opened or damaged. Do not re-sterilize. Where long-term use is indicated, it is recommended that indwelling time not exceed 90 days. This catheter should be evaluated by the physician on or before 90 days post- placement.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


EXODUS

Important Risk Information
INDICATIONS FOR USE/INTENDED USE: Multipurpose Drainage Catheters are intended for percutaneous drainage of fluid or air from the chest, abdomen and pelvis. Nephrostomy Drainage Catheters are intended for percutaneous drainage of fluid collections in the urinary system.

 

CONTRAINDICATIONS: Bleeding diathesis; anticoagulant use.

 

WARNINGS: Do not use catheter for gastrostomy procedures/feeding tube. Exposure to gastric juices may damage the catheter. Do not place catheter into the vascular system. Do not expose this catheter to alcohol, as it may damage the hydrophilic coating and the catheter. This product contains a metallic component that has the potential for movement under MRI.

 

CAUTION: Do not wipe coated portion of catheter with dry gauze or expose coating to alcohol or solvents, as it may damage the hydrophilic coating.

 

Refer to Directions for use provided with the product for complete instructions, warnings and precautions/cautions.

 

CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


NIT-VU

Important Risk Information
INDICATION FOR USE: The Nit-Vu* High-Performance Micro Guidewire is designed to facilitate the placement of devices for diagnostic and interventional procedures.

 

For single use only.

 

CONTRAINDICATIONS: These guidewires are not intended for PTCA use.

 

WARNINGS AND PRECAUTIONS: This device is not intended for use in the coronary arteries or the neurovasculature. Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.  Reprocessing may compromise the integrity of the device and lead to device failure. 

 

Please see package insert for complete list of warnings and cautions.

 

CAUTION:  Federal (USA) law restricts these devices to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


Mini Stick MAX

Important Risk Information
INDICATION FOR USE
: The coaxial microintroducer kit is used for the percutaneous introduction of a guidewire into the vascular system.

 

CONTRAINDICATIONS: None known.

 

WARNINGS: Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found, call your AngioDynamics representative. Inspect prior to use to verify that no damage has occurred in shipping. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or crossinfection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and/ or local government policy.

 

POTENTIAL ADVERSE EFFECTS: Air embolism, bleeding, guidewire shearing, fracture or embolization, hematoma, infection, infl ammation, necrosis or scarring, laceration or perforation of a vessel or viscus, pain in region, skin infection.

 

CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


NAMIC Fluid Management

NAMIC COMPENSATOR
INTENDED USE/INDICATIONS FOR USE: Physiological pressure transducers are utilized during invasive pressure monitoring, catheterization procedures and fluid delivery.

 

CONTRAINDICATIONS: None known.

 

WARNINGS: Do not exceed the following pressures when using this device - Main lumen: Medium Pressure Manifolds – 1379 kPa (200 psi/14bar) Static pressure; High Pressure Manifolds – 3447 kPa (500 psi/35 bar) Static pressure; Transducer Side Port – 41 kPa (6 psi/300 mmHg). Do not use if package is opened or damaged.

 

PRECAUTIONS: The Compensator line must be completely filled with saline to produce accurate pressure readings. The female luer end of the Compensator line (placed in a compatible mounting plate) must be at heart level in order to produce accurate readings. During fluid injection through the main lumen of the manifold, ensure proper orientation of the handles so that fluid does not enter the side ports. Do not use transducer Zero/ Compensator Port as an injection site for fluids.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

NAMIC ANGIOGRAPHIC CONTROL SYRINGE
INTENDED USE/INDICATIONS FOR USE: The NAMIC Angiographic Control Syringe is intended to be used for the intraarterial or intravenous administration of radiographic contrast media.

 

CONTRAINDICATIONS: None known.

 

WARNINGS: Do not store fluid in product. Inject immediately after filling. This syringe does not have a pressure gauge device. Therefore, it is not intended for balloon catheter inflation. Over inflation may result in the rupturing of the balloon.

 

CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

NAMIC STOPCOCKS
INTENDED USE/INDICATIONS FOR USE: NAMIC Stopcocks are intended for use in hemodynamic monitoring procedures and for intraarterial and intravenous administration of water-based solutions or radiographic contrast media.

 

CONTRAINDICATIONS: None known.

 

WARNINGS: NAMIC Stopcocks are not recommended for use with lipids. Prolonged exposure to lipid solutions may result in stress cracking or leakage.

 

CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

NAMIC PERCEPTOR DT DISPOSABLE TRANSDUCER
INTENDED USE/INDICATIONS FOR USE: Physiological pressure transducers are utilized during invasive pressure monitoring, catheterization procedures and fluid delivery.

 

CONTRAINDICATIONS: None known.

 

WARNINGS: Check for fluid leakage before and during the procedure. Leaks can result in the loss of sterility, fluid or blood loss, and/or air embolism. If a productleaks before or during use, retighten the leading connection or replace the product. This product does not incorporate protection from accidental over pressurization. Over pressurizing may permanently impair the accuracy of the device. Do not exceed the following pressure when using this device: 41 kPa (300 mmHg/6 psi).

 

PRECAUTIONS: Carefully read these instructions before using this product. If this product is being used in conjunction with other manufacturers’ components, also read their instructions for use. Use proper aseptic techniques while handling this product. The presence of air in the system may dampen the transmission of the patient’s pressure to the transducer. Be sure to eliminate all air bubbles. Do not use transducer port as a main injection site for fluids.

 

CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

NAMIC SQUEEZE CONTROLLER
INTENDED USE/INDICATIONS FOR USE: The purpose of this system is to minimize contrast waste and allow one container of contrast media to be used on more than one patient.

 

CONTRAINDICATIONS: None known.

 

WARNINGS: Maintenance of sterility can only be achieved through proper set-up and use. Use proper aseptic technique when handling this device. Do not attempt to flush contrast media or air bubbles back through the contrast delivery system when the Squeeze Contrast Controller chamber is full of fluid. Flushing back through a full Squeeze chamber could damage the two check valves above the chamber and compromise the sterility of the spike assembly and contrast container. Do not use the spike assembly on more than one container of contrast media. Do not use the tubing assembly on more than one patient. Do not leave the spike assembly intact in a container of contrast for longer than six (6) hours. Do not replace the tubing assembly more than two (2) times. If there is any possibility that contamination may have occurred during set-up or use, disassemble and set up new sterile product. Ensure that you are making secure connections when using this device to prevent the introduction of air into the system that could result in embolism and in rare instances death. All connections should be finger tightened. Over tightening can cause cracks and leaks to occur that could result in embolism and or exposure to biohazards. Examine product carefully for entrapped air and fully debubble prior to injection to minimize the potential for embolism and in rare instances death.

 

PRECAUTIONS: Carefully read these instructions completely prior to use. The chamber must hang vertically for the green ball to operate effectively.

 

CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

ANGIODYNAMICS HIGH PRESSURE CONNECTING LINES

INTENDED USE/INDICATIONS FOR USE: The AngioDynamics High Pressure Connecting Lines intended use is to deliver contrast media during angiographic procedures.

 

NAMIC DEVICES: CONTRAST INJECTION LINES

INTENDED USE/INDICATIONS FOR USE: These devices are intended to be used in fluid management and/or invasive pressure monitoring systems.

 

CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

ANGIOGRAPHIC CORE WIRES
INDICATION AND USAGE: Guidewires are intended for use in the percutaneous introduction of catheters.

 

CONTRAINDICATIONS: None known.

 

WARNINGS: Do not withdraw the guidewire through a metal cannula needle. Withdrawal may damage the guidewire or coating. If strong resistance is met during manipulation, discontinue the procedure and determine the cause for the resistance before proceeding. Avoid bending, kinking or modifying the shape of the wire.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

NAMIC DEVICES: ADAPTORS, TORQUE DEVICES, GUIDEWIRES
INTENDED USE/INDICATIONS FOR USE: These devices are intended to be used in fluid management and/or invasive pressure monitoring systems.

 

CAUTION: Federal Law (USA) restricts these devices to sale by or on the order of a physician.

 

THE ENCORE 26 INFLATION DEVICE
INTENDED USE/INDICATIONS FOR USE: The Encore 26 Inflation Device is recommended for use with balloon dilatation catheters to create and monitor pressure in the balloon, and to deflate the balloon.

 

CONTRAINDICATIONS: None known.

 

WARNINGS: None known.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

NAMIC Y-ADAPTORS AND TRI-ADAPTORS
INTENDED USE/INDICATIONS FOR USE: NAMIC Y-Adaptors and Tri-Adaptors are recommended for supporting a fluid tight seal around percutaneous transluminal catheters and guidewires.

 

CONTRAINDICATIONS: None known.

 

WARNINGS: Excessive aspiration rate through the angled side port may result in air bypass through the hemostatic valve.

 

PRECAUTIONS: Do not over tighten the Y-Adaptor hemostatic valve(s). This may cause the lumen of the catheter to collapse and/or impair free movement of the wire. Always be sure that the hemostatic valve(s) is/are completely closed during aspiration or injection. The user of this device should carefully consider the size of the device to be inserted through the Y-Tri-Adaptor when selecting the size of the Y-Tri-Adaptor to be used. Pressures greater than 200 psi (1379 kPa) may result in leakage or detachment of components.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

GATEWAY PLUS Y-ADAPTOR
INTENDED USE/INDICATIONS FOR USE: The GateWay Plus Y-Adaptor is recommended for providing hemostasis around balloon dilatation catheters, guidewires, and other therapeutic devices during general intravascular procedures.

 

PRECAUTIONS: Prior to angioplasty, all equipment to be used for the procedure, including the dilatation catheter, should be carefully examined to verify proper function. This device should be used only by physicians thoroughly trained in angioplasty procedures. Before use of this device, administer appropriate anticoagulant. Do not over tighten the adjustable valve. Excessive tightening may inhibit the ability to manipulate the balloon dilation catheter, guidewire or other therapeutic device and may also significantly increase dilatation catheter inflation/deflation times. Since therapeutic devices are fragile, exercise care during handling to reduce the possibility of accidental breakage. If resistance is felt during manipulation, discontinue further movement and determine the cause. Ensure that the balloon dilatation catheters are completely deflated before inserting or withdrawing the balloon through the GateWay Plus Adaptor.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

AVENUE INSERTION TOOL
INTENDED USE/INDICATIONS FOR USE: The Avenue Insertion Tool is used to facilitate the introduction of a guidewire during general intravascular procedures.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

TD2 TORQUE DEVICE
INTENDED USE/INDICATIONS FOR USE: The TD2 Torque Device is used for guidewire manipulation during general intravascular procedures.

 

WARNINGS: This device should be used only by physicians thoroughly trained in angioplasty procedures.

 

PRECAUTIONS: Do not over tighten the polymer cap. Excessive tightening may abrade the guidewire coating and make loosening difficult. Should the cap be accidentally removed from the TD2 Torque Device, the collett must be seated in the body before the cap can be put on again.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

THE GRIP TORQUE DEVICE
INTENDED USE/INDICATIONS FOR USE: The Grip Torque Device provides a convenient gripping surface for manipulating steerable guidewires and hypotube style fixed wire catheters used in coronary balloon dilatation. The Grip Torque Device may also be used as an adjustable stop to limit the advancement of the steerable guidewire within the dilatation catheter.

 

CONTRAINDICATIONS: None known.

 

WARNINGS: The Grip Torque Device should be used only by physicians thoroughly trained in the technique of percutaneous transluminal coronary angioplasty. Do not use on the polymer portion of any catheter. Do not use if package is opened or damaged.

 

PRECAUTIONS: Use prior to the “Use By” date on the package.

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

NAMIC PROTECTION STATION PLUS, PROTECTION STATION PLUS WITH CONTRAST CONTROLLER CHECK VALVE SYSTEM
INTENDED USE/INDICATIONS FOR USE: The Protection Station Plus and Protection Station Plus with Contrast Controller Check Valve System are used for syringe flush, fluid administration and waste containment. In addition, the Protection Station Plus with Contrast Controller Check Valve System is also used to minimize contrast waste and to allow one container of contrast media to be used on more than one patient.

 

WARNINGS: Do not attempt to flush contrast media or air bubbles back through the Contrast Controller Check Valve System. The red handled four-way stopcock must be “off” to the Contrast Controller Check Valve system when flushing fluids into ANGIO-SAC* Collection Bag. Do not use Contrast Controller Spike Assembly on more than one container of contrast media. Do not use Protection Station Plus with Contrast Controller Check Valve System on more than one patient. Do not leave the Contrast Controller Spike Assembly intact in a container of contrast for longer than six (6) hours. Do not replace the Contrast Controller Tubing Assembly more than two (2) times. If there is any possibility that contamination may have occurred during set-up or use, disassemble and set up new sterile product.

 

PRECAUTIONS: Pressurized systems are intended for use with non-vented spikes. If using a vented spike in a pressurized system, close the vent flap. In non-pressurized fluid applications, verify that the roller clamp is completely open to allow for the proper flow of the fluid during syringe aspirations. To reduce the possibility of backcheck valve leakage, limit fluid bag height to 36 inches (91 cm) or less. Do not pressurize the system in excess of 300 mmHg (6 psi, 41 kPA).

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

NAMIC PROTECTION STATION
INTENDED USE/INDICATIONS FOR USE: The Protection Station is used for syringe flush, fluid administration and waste containment.

 

CONTRAINDICATIONS: None known.

 

PRECAUTIONS: Use proper aseptic technique while handling this product. Pressurized systems are intended for use with non-vented spikes. If using a vented spike in a pressurized system, close the vent flap. In non-pressurized fluid applications verify that the roller clamp is completely open to allow for the proper flow of the fluid during syringe aspirations. To reduce the possibility of back check valve leakage, limit fluid bag height to 36 inches (91 cm) or less. To prevent fluid loss with pressurized fluid applications, do not pressurize the system until the back check valve is connected to a stopcock, manifold or reflux valve. Do not pressurize the system in excess of 41 kPa (300 mmHg/6 psi).

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.

 

NAMIC ACCESSORIES
INTENDED USE/INDICATIONS FOR USE: Accessories are intended to be used in fluid management and/or invasive pressure monitoring systems

 

Contraindications: None known

 

Refer to Directions for Use and/or User Manual provided with the product for complete Instructions, Warnings, Precautions, Possible Adverse Effects and Contraindications. Observe all instructions for use prior to use. Failure to do so may result in patient complications.


AngioVac

Important Risk Information

CANNULA INDICATION FOR USE: The Vortex Medical AngioVac Cannula is indicated as a venous drainage cannula during extracorporeal bypass for up to 6 hours. The cannula is also indicated for removal of soft, fresh thrombi or emboli utilizing extracorporeal bypass for up to 6 hours.

 

CIRCUIT INDICATION FOR USE: The AngioVac Extracorporeal bypass circuit is intended for use in procedures requiring extracorporeal circulatory support for periods up to six hours.

 

CONTRAINDICATIONS: Alone, this cannula is not a medical treatment device. Selection of the patient as a candidate for use with this device and for such procedures as it is intended is the physicians’ sole responsibility. The outcome is dependent on many variables including, patient pathology, surgical procedure, and perfusion procedure/technique. Do not use if the patient has severe arterial or venous vascular disease. The device is contraindicated in the removal of fibrous or calcified material (e.g., atherosclerotic plaque). The device is contraindicated for use in the right heart or pulmonary arteries during active cardiopulmonary resuscitation.

 

WARNING: For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilizing may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilizing may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

 

Cleared for the removal of soft, fresh thrombi or emboli only outside the US.