Warnings - Contents supplied STERILE using an ethylene oxide (EO) process. Do not use product if sterile barrier is damaged. If the product is damaged call your Boston Scientific Representative.
For single 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 cross-infection, including, but not limited to, transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
Due to the risk of exposure to HIV (Human Immunodeficiency Virus) or other blood borne pathogens, health care workers should routinely use universal blood and bodyfluid precautions in the care of all patients. Sterile technique must be strictly adhered to during any handling of the device.
Potential Adverse Effects
Although the Vaxcel® Implantable Ports with PASV® Valves have been engineered for optimal safety, there are inherent risks associated with any implantable device. These include the following:
- Air or catheter embolism
- Arteriovenous fistula
- Brachial plexus injury
- Cardiac arrhythmia
- Cardiac tamponade
- Catheter or port erosion through skin/vessel
- Catheter occlusion, malposition, dislodgment, fragmentation, migration, disconnection, or rupture
- Catheter occlusion or breakage caused by pinching between clavicle and first rib
- Catheter thrombosis
- Drug extravasation
- Embolism of catheter fragments
- Implantation site necrosis or infection
- Fibrin sheath formation
- Implant rejection
- Implant rotation or extrusion
- Laceration or perforation of vessel
- Thoracic duct injury
- Vascular thrombosis
- Nerve damage
- Tunnel infection
- Risks normally associated with local and general anesthesia, surgery, and post-operative recovery
Avoid handling the catheters with sharp objects. Silicone rubber may be easily cut or torn. When handling the catheter, padded hemostats, vascular clamps, or tube occluding forceps should be used. INSTRUMENTS WITH TEETH SHOULD NEVER BE USED TO GRASP THE CATHETER. DAMAGING THE CATHETER PRIOR TO OR DURING INSERTION MAY CAUSE CATHETER FRACTURE IN THE VESSEL. The catheter should only be grasped at the end that will be trimmed prior to insertion.