PT Graphix™ Guide Wire
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.
Boston Scientific ChoICE™ PT, PT Graphix™, ChoICE, Luge, and Mailman Guidewires with ICE™ Hydrophilic Coating are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.
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
- Hemorrhage or hematoma
- Infection, local infection, systemic infection
- Pain at the access site
- Vascular thrombus
- Vessel spasm
- Vessel trauma (dissection, perforation, rupture or injury)
In addition, when used for PTCA:
- Abrupt closure
- Angina or unstable angina
- Cardiac tamponade/pericardial effusion
- Contrast induced renal insufficiency or renal failure
- Myocardial infarction or ischemia
- Stroke/cerebral vascular accident (CVA)/transient ischemic attack (TIA)
Boston Scientific (Master Brand DFU Template 3in x 9in Global, 90106040AJ), DFU, MB, CV Guidewires, Global, 90555713-01A_pretrans
Some of the above potential adverse events may require additional surgical intervention.