POWERPORT® Port Features

Description

The PowerPort® implantable port is an implantable access device designed to provide repeated access to the vascular system. Port access is performed by percutaneous needle insertion using a non-coring needle. Power injection is performed using a POWERLOC® Brand Safety Infusion Set* only. The PowerPort® device consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque catheter. Single lumen PowerPort® implantable ports can be identified subcutaneously by feeling the top of the septum which includes three palpation bumps arranged in a triangle and by palpating the sides of the port, which is also triangular. Dual lumen PowerPort® implantable ports can be identified subcutaneously by feeling the top of each septum; each septum features three palpation bumps arranged in a triangle. All materials are biocompatible, can be used with virtually all injectable solutions intended for medicinal use, including the power injection of contrast media. For implantable ports with GROSHONG® catheters, the GROSHONG® catheter valve helps provide security against blood reflux and air embolism into the port/catheter system. The GROSHONG® catheter may be flushed with normal saline, and it does not require heparin to maintain patency.

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® Brand Safety Infusion Set*, the PowerPort® device 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 pinch-off.1,2 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.
  • 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® Brand 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® device 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® device.
  • If local pain, swelling or signs of extravasation are noted during power injection, the injection should be stopped immediately.

Signs of Pinch-Off

Clinical:

  • Difficulty with blood withdrawal
  • Resistance to infusion of fluids
  • Patient position changes required for infusion of fluids or blood withdrawal

Radiologic:

  • Grade 1 or 2 distortion on chest X-ray. Pinch-off should be evaluated for degree of severity prior to explantation. Patients indicating any degree of catheter distortion at the clavicle/first rib area should be followed diligently. There are grades of pinch-off that should be recognized with appropriate chest x-ray as shown in the table at right.3,4
Pinch-Off Grade Table

Precautions

  • Carefully read and follow all instructions in these instructions for use.
  • Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
  • Only qualified healthcare practitioners should insert, manipulate and remove these devices.
  • Avoid inadvertent puncture of the skin or fascia with the tip of the tunneler.
  • If the guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire.
  • Use only non-coring needles with the port.
  • Prior to advancing the catheter lock, ensure that the catheter is properly positioned. A catheter not advanced to the proper region may not seat securely and lead to dislodgment and extravasation. The catheter must be straight with no sign of kinking. A slight pull on the catheter is sufficient to straighten it. Advancing the catheter lock over a kinked catheter may damage the catheter. Do not hold the catheter or cathlock with any instruments that could potentially damage either piece (e.g. hemostats).
  • Follow universal precautions when inserting and maintaining the catheter.
  • Follow all contraindications, warnings, precautions and instructions for all infusates as specified by their manufacturers.
  • Precautions are intended to help avoid catheter damage and/or patient injury.

I. Prior to Placement:

  • Examine package carefully before opening to confirm its integrity and that the expiration date has not passed. The device is supplied in a double sterile package and is non-pyrogenic. Do not use if package is damaged, opened or the expiration date has passed. Sterilized by ethylene oxide. Do not resterilize.
  • Inspect kit for presence of all components.
  • Check patient’s records, and ask patient, whether they have any known allergies to chemicals or materials that will be used during the placement procedure.
  • Fill (prime) the device with sterile normal saline solution to help avoid air embolism.
  • When using an introducer kit, verify that the catheter fits easily through the introducer sheath.
  • When utilizing port for arm placement, the port should not be placed in the axillary cavity.
  • Bard Access Systems, Inc. recommends the use of components provided in the kit. If additional items are to be used, check for proper fit prior to utilization.
    Note: Port body, catheter and catheter lock cannot be replaced with components outside the provided kit.

II. During Placement:

  • Do not allow accidental device contact with sharp instruments. Mechanical damage may occur. Use only smooth edged, atraumatic clamps or forceps.
  • Take care not to perforate, tear, or fracture the catheter during placement. After assembling catheter to port, check assembly for leaks or damage.
  • Do not use the catheter if there is any evidence of mechanical damage or leaking.
  • Do not bend catheter at sharp angles during implantation. This can compromise catheter patency.
  • Carefully follow the connection technique given in these instructions to ensure proper catheter connection and to avoid catheter damage.
  • Do not use sutures to secure catheter to the port stem as it could collapse or damage the catheter.
  • When using peel-apart introducers:
    • Carefully insert the introducer and catheter to avoid inadvertent penetration to vital structures in the thorax.
    • Avoid blood vessel damage by maintaining a catheter or dilator as internal support when using a peel-apart introducer.
    • Avoid sheath damage by simultaneously advancing the sheath and dilator as a single unit using a rotational motion.
  • Never use a catheter lock that appears cracked or otherwise damaged.

II. After Placement:

  • Encourage patient to keep patient ID card and present it to clinicians accessing their port.
  • Care should be taken to avoid excessive force when accessing an implanted port.

 

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