PT²™ Moderate Guide Wire
Indications, Safety and Warnings
Prescriptive Information
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
Boston Scientific Guidewires are intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. Refer to the product label for any additional product-specific indications that may apply.
CONTRAINDICATIONS
Boston Scientific Guidewires are not intended for use in the cerebral vasculature. Refer to the product label for any additional product-specific contraindications that may apply.
WARNINGS
Contents supplied STERILE using an ethylene oxide (EO) process.
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.
Guidewires should be used only by physicians thoroughly trained in their intended use.
Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated. Severe reaction may occur in response to contrast agents that cannot be adequately premedicated.
ADVERSE EVENTS
Potential adverse events which may result from the use of the device include but are not limited to:
- Allergic reaction to contrast media
- Embolism
- Hemorrhage or hematoma
- Infection, local infection, systemic infection
- Pain at the access site
- Pseudoaneurysm
- Vascular thrombus
- Vessel spasm
- Vessel trauma (dissection, perforation, rupture or injury)
In addition, when used for PTCA:
- Abrupt closure
- Angina or unstable angina
- Arrhythmias
- Cardiac tamponade/pericardial effusion
- Contrast induced renal insufficiency or renal failure
- Death
- Myocardial infarction or ischemia
- Stroke/cerebral vascular accident (CVA)/transient ischemic attack (TIA)
Some of the above potential adverse events may require additional surgical intervention.