Indications For Use

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

Refer to the Instructions for Use for complete instructions for use.

INDICATIONS FOR USE

The Implantable Port is designed for patients who require long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal.

CONTRAINDICATIONS

Venous access to the upper torso may be contraindicated due to anatomical constraints, such as burns to the upper body, cervicothoracic trauma, planned radiation therapy to the mediastinum, bilateral neck dissection, infected median sternotomy incisions, and venous thrombosis. In these circumstances,  cannulation of the inferior vena cava may be necessary.

WARNINGS

1. DO NOT use the port for high-pressure injections, i.e. diagnostic procedures. Ensure that the pressure alarm feature of infusion pumps used with the port does not exceed a maximum of 25 psi (172 kPa). DO NOT use small diameter syringes (less than 10 ml) for injection as they can create very high pressures, which may result in catheter rupture. Do not exceed 25 psi (172 kPa).
2. The catheter should be placed with care to avoid inadvertent penetration of vital structures in the thorax by the percutaneous introducer or the catheter.
3. Percutaneous insertion of the catheter into the axillary or subclavian veins should be accessed at the junction of the outer and mid-thirds of the clavicle lateral to the thoracic outlet. Avoid placement into the subclavian vein medially, because such placement can lead to compression of the catheter (pinch-off
   syndrome) between the first rib and the clavicle which can result in damage, fracture or embolization of the catheter. Fluoroscopic or radiographic confirmation of catheter tip placement should be made to ensure correct location of the tip in the SVC/right atrial junction and to establish lack of “pinch-off”.
   NOTE: Pinch-off may not be noticeable immediately post-insertion.
4. When using a multi-lumen port with a pre-attached catheter, caution should be exercised when infusing incompatible medications since the distal openings on the catheter are not staggered.
5. Testing has indicated that each septum can withstand over 1200 punctures with a 20-gauge (1 mm) or 1700 punctures with a 22-gauge (0.67 mm) non-coring needle. Should the number of punctures rise above 1000, septum leakage is possible.

PRECAUTIONS

• Avoid catheter contact with sharp instruments. Care must be exercised when implanting the Implantable Port to avoid mechanical damage to the silicone catheter. The catheter should not be used if there is any evidence of mechanical damage or leakage.
• Catheters should be implanted carefully to avoid any sharp or acute angles, which could compromise the integrity or the functionality of the catheter lumen.
• Maintain aseptic technique during all port implantation, use and maintenance procedures.
• DO NOT use the port with chemicals that are incompatible with any of its components as catheter damage could occur.
• DO NOT re-sheath any needles. Place needle(s) in puncture-resistant, leak-proof sharps container per institutional protocol.
• The port body may be placed in a number of areas in the body, and the catheter may be placed in any number of veins. Use the procedure and technique which is most appropriate for your experience and needs as well as for the patient.
• The instructions for implantation and maintenance provided in this manual should be followed to avoid circumstances that could jeopardize port integrity or functionality.
• The nurse or physician is responsible for all patient instructions regarding flushing, use, and maintenance procedures.
• The use of this port should be preceded by the establishment of institutional protocols. Recommendations for the insertion, use, and maintenance of the device are provided in this manual to serve as a guide for the generation of those protocols.

POSSIBLE COMPLICATIONS

The potential for serious complications exists with the implantation and use of any type of subcutaneous port system. Port implantation should be performed only when the potential benefits outweigh the inherent risks of the procedure. Implantation and care of the Implantable Port should only be performed by persons knowledgeable of the risks involved and qualified in the procedures. The following complications and adverse reactions are well-documented in the scientific literature and should be considered before implanting the port.

• Air or Catheter Embolism
• Extravasation
• Allergic Reaction
• Fibrin Formation
• Bleeding
• Hematoma
• Brachial Plexus Injury
• Hemothorax
• Cardiac Tamponade
• Hydrothorax
• Catheter Damage
• Laceration of Vessels or Viscus
• Catheter or Port Erosion through the skin
• Pneumothorax
• Portal Site Necrosis
• Catheter or Port Occlusion
• Thoracic Duct Injury
• Catheter Pinch Off (occlusion, damage, breakage)
• Thromboembolism
• Tissue Necrosis
• Catheter Tip Migration
• Venous Thrombosis
• Catheter or Port-related Sepsis
• Vessel Erosion
• Death
• Emboli
• Endocarditis
• Risks associated with general and local anesthesia, surgery and Post-op Recovery