IMPULSE™ Diagnostic Catheter
Indications, Safety and Warnings
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. 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 FOR USE
Boston Scientific 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.
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 principles, clinical applications and risks associated with angiography is necessary before performing this procedure.
Potential adverse reactions which may result from the use of this device include but are not limited to:
- Access site pain
- Allergic and neurological reactions
- Hemorrhage or hematoma
- Impaired blood flow due to thrombosis, embolism, or vasospasm that could lead to myocardial infarction, stroke, transient ischemic attack (TIA), limb amputation, and other thrombo-embolic organ damages such as renal infarction
- Organ failure
- Vessel trauma
In addition, the use of contrast may cause renal failure or other adverse reactions.