Potential Adverse Events; Patient Counseling Information - COOK Vital-Port Instrucciones De Uso

• Verify that the catheter lock and reinforcing sleeve are retrieved, along with the port body and total length of the
catheter, upon removal of the Vital-Port System. A post operative x-ray is suggested for verification.
Accessing the Port
• Follow all manufacturer guidelines for infusates.
• Do not exert excessive force during needle insertion. The needle point may become damaged and could tear the
septum when the needle is removed.
• Do not exceed 40 psi pressure when administering fluid through the system. Use of a 10 mL or larger syringe is
recommended for all injection and flushing procedures. Pressures in excess of 40 psi can be generated with most
syringes; the smaller the syringe, the higher the pressure that can be generated. For Vital-Port system models that are
labeled as a POWER INJECTABLE PORT, refer to the Contrast Power Injection using Vital-Port System section in these
Instructions for Use.
• Inspect and replace the infusion set and sterile dressing according to CDC guidelines, or at intervals according to
hospital policy or current practice.

POTENTIAL ADVERSE EVENTS

Use of the Vital-Port System involves potential risks normally associated with the insertion or use of any implanted
device or indwelling catheter. These include, but not limited to: air embolism; bacteremia, infection; sepsis; brachial
plexus injury; cardiac arrhythmia, puncture, or tamponade; catheter disconnection, fracture, fragmentation, malposition,
pinch-off, rupture, or shearing; embolization, extravasation, or formation of calcium-like deposits; fibrin sheath formation;
hemothorax; hematoma; port/catheter erosion, migration, occlusion, rejection, or rotation; pneumothorax; thoracic duct
injury; thrombosis; thromboembolism; vessel erosion, laceration, perforation, or trauma.

PATIENT COUNSELING INFORMATION

Each Vital-Port System is supplied with a patient information card, containing the port model and lot number as well as
manufacturer contact information. Please complete the requested information on the card and instruct the patient to carry
the card with him or her.
A "Patient Information" booklet is also supplied with each port or available separately.
INSTRUCTIONS FOR USE: PLACEMENT
System Preparation
Prior to placement, all air must be flushed from the chamber(s) and catheter lumen(s) of the Vital-Port system using a non-
coring needle, a 10mL or larger syringe, and heparinized saline (100 IU/mL).
CAUTION: Use aseptic techniques and extreme care when handling the catheter. Avoid both contacting the catheter with
sharp objects (which may lead to catheter shearing) and excessive clamp force (which could damage the catheter). Clamp
the catheter only on a section that will be cut off prior to implant. If the catheter was previously cut to length, keep the
distal end elevated rather than clamping. When trimming catheter to size, perform a perpendicular cut in one motion.
Port Placement Considerations
• The injection port reservoir should be placed where it will be supported by an underlying bony structure. The location
should be convenient and comfortable for the patient. Patient mobility should also be considered.
• The incision should not be significantly larger than the length of the port base. Avoid positioning the port septum
directly below the incision line since the septum will be punctured repeatedly.
• The port should not be placed too deeply to be easily located, or too superficially, causing erosion due to pressure
necrosis. A depth between 0.5cm and 2cm under the skin surface is recommended. The port should be easily located
by palpation for access.
Catheter Placement Considerations
• The catheter tip should be placed in an area of high blood flow (usually the SVC) Figure 3.
• To allow for body movement, the catheter should not be implanted with tension. Also avoid excessive catheter slack in
the port pocket to prevent possible kinking.
5