Prescriptive Information
Untitled Document
Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.
Indications
Boston Scientific Corporation Angiographic Catheters are designed to provide a pathway to be used for delivering contrast media to selected sites in the vascular system during an angiographic procedure.
Contraindications
None known.
Warnings
- Contents supplied STERILE using an ethylene oxide (EO) process. Do not use if sterile barrier is damaged. If damage is found call your Boston Scientific representative.
- For single patient 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, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.
- Do not exceed the pressure ratings printed on the label. Catheter integrity may be compromised if the pressure exceeds the maximum pressure listed
Potential Adverse Effects
Other potential adverse reactions which may result from the improper use of the device include blood loss, infection, hematoma at the puncture site, arterial wall damage, plaque dislodgement, and air embolism.
Cautions
Angiographic catheters are designed for use by physicians engaged in the practice of a specialized branch of medicine. Use of these devices should be restricted to those specialists trained to perform the procedure. A thorough understanding of the technical principals, clinical applications and risk associated with angiography is necessary before performing this procedure.
- Do not use open or damaged packages. Store in a dry, dark, cool place.
- Use prior to the "Use Before" date.
- Do not expose catheters to strong solvents.
- To avoid damaging the tip of the catheter during removal from the package, open as follows: Grasp the hub and slowly withdraw the catheter. Rapid removal may result in damage to the catheter tip.
- Carefully inspect the catheter prior to use to verify the size and shape as suitable for the specific procedure and that it has not been damaged during handling.
- Rotate inventory to maintain fresh stock.
- Angiographic catheters should only be manipulated while under floroscopic observations.
- To facilitate the introduction and avoid damage at the puncture site, the angiographic catheter should be introduced using a guide wire.
- Precautions to prevent or reduce clotting should be taken when any catheter is used. While in the vascular system, the catheter should always be filled with either flushing solution or contrast medium. Use of systemic heparinization should be considered.
- If pigtail straightener is used, verify that it is removed from catheter shaft/sheath before advancing catheter.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Trademark
Impulse and Expo are trademarks of Boston Scientific Corporation or its affiliates.
