PowerPort™ ClearVUE™ Implantable Ports

Indications For Use

The PowerPort™ implantable port is indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples.

When used with a PowerLoc™ Safety Infusion Set, the PowerPort™ implantable port is indicated for power injection of contrast media. For power injection of contrast media, the maximum recommended infusion rate is 5 mL/s.

Contraindications

This device is contraindicated for:

• Catheter insertion in the subclavian vein medial to the border of the first rib, an area which is associated with higher rates of pinchoff. Port may be placed in lateral subclavian vein based on evaluation by a qualified practitioner.

• When the presence of device-related infection, bacteremia, or septicemia is known or suspected.

• When the patient’s body size is insufficient for the size of the implanted device.

• When the patient is known or is suspected to be allergic to materials contained in the device. The device is primarily comprised of silicone, polyacetal, polyetheretherketone, and/or titanium.

• If severe chronic obstructive lung disease exists.

• If the prospective insertion site has been previously irradiated.

• If the prospective placement site has previously suffered episodes of venous thrombosis or vascular surgical procedures.

• If local tissue factors will prevent proper device stabilization and/or access.

Warnings

I. During Placement:

• Intended for Single Use. Do not reuse. Reuse and/or repackaging may create risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure and/or lead to injury, illness or death of the patient.

• Alcohol should not be used to soak or declot a polyurethane catheter because alcohol is known to degrade the polyurethane catheter over time with repeated and prolonged exposure.

• After use, this product may be a potential biohazard. Handle and discard in accordance with accepted medical practice and applicable local, state and federal laws and regulations.

• Place thumb over exposed opening of sheath or needle or attach syringe filled with sterile normal saline solution to minimize blood loss and prevent air embolism. The risk of air embolism is reduced by performing this part of the procedure with the patient performing the Valsalva maneuver and/or in Trendelenburg position.

• Do not suture catheter to port, port stem, or surrounding tissue. Any damage or constriction of catheter may compromise power injection performance and catheter integrity. Bard Access Systems, Inc. does not recommend suturing around the catheter as doing so could compress, kink, or damage catheter, including catheter fragmenting and/or fracturing.

• Do not manipulate a pre-assembled or pre-connected catheter/port connection, as the catheter could become disconnected from the port, or system damage could occur.

• Do not attempt to measure the patient’s blood pressure on the arm in which a peripheral system is located, since catheter occlusion or other damage to the catheter could occur.

• Avoid vessel perforation.

• Do not power inject through a port system that exhibits signs of clavicle-first rib compression or pinch-off as it may result in port system failure.

• For implantable ports with Groshong® catheters, do not cut stylet. Withdraw stiffening stylet from catheter prior to cutting.

• Failure to completely advance the catheter on the dual lumen stem may result in subcutaneous leakage.

II. During Port Access:

• Do not use a syringe smaller than 10 mL. Flushing occluded catheters with small syringes can create excessive pressures within the port system.

• PowerPort™ implantable ports are only power injectable when accessed with a PowerLoc™ Safety Infusion Set.

• Failure to warm contrast media to body temperature prior to power injection may result in port system failure.

• Failure to ensure patency of the catheter prior to power injection studies may result in port system failure.

• Power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter.

• Exceeding the maximum flow rate may result in port system failure and/or catheter tip displacement.

• PowerPort™ implantable port indication for power injection of contrast media implies the port’s ability to withstand the procedure, but it does not imply appropriateness of the procedure for a particular patient nor for a particular infusion set. A suitably trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure and for evaluating the suitability of any infusion set used to access the port.

• Do not exceed a 300 psi pressure limit setting on the power injection machine, or the maximum recommended flow rate on the PowerLoc™ needle, if power injecting through the PowerPort® implantable port.

• If local pain, swelling or signs of extravasation are noted during power injection, the injection should be stopped immediately.

Possible Complications

The use of a subcutaneous port provides an important means of venous access for critically ill patients. However, the potential exists for serious complications, including the following:

Air Embolism, Allergic Reaction, Bleeding, Brachial Plexus Injury, Cardiac Arrhythmia, Cardiac Puncture, Cardiac Tamponade, Catheter or Port Erosion Through the Skin, Catheter Embolism, Catheter Occlusion, Catheter or port-related Sepsis, Damage or Breakage due to Compression between the Clavicle and First Rib, Device Rotation or Extrusion, Endocarditis, Extravasation, Fibrin Sheath Formation, Guidewire Fragment Embolism, Hematoma, Hemothorax, Hydrothorax, Infection, including but not limited to, pocket, catheter tunnel, and/or blood stream, Inflammation, Necrosis, or Scarring of Skin Over Implant Area, Intolerance or Reaction to Implanted Device, Laceration of Vessels or Viscus, Pain at or around port pocket site, Perforation of Vessels or Viscus, Pneumothorax, Risks Normally Associated with Local or General Anesthesia, Surgery, and Post-Operative Recovery, Spontaneous Catheter Tip Malposition or Retraction, Thoracic Duct Injury, Thromboembolism, Vascular Thrombosis, Vessel Erosion

Please consult product labels and package inserts for indications, contraindications, hazards, warnings, cautions, possible complications, and information for use.

BD-90736