FORTÉ™ Floppy 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
The Boston Scientific PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other therapeutic devices during PTCA or other intravascular interventional procedures. The guide wires are not intended for use in the cerebral vasculature.
WARNINGS/ADVERSE REACTIONS
Other potential adverse reactions which may result from the improper use of this device include, but are not limited to: Air embolism, hematoma at the puncture site, infection and perforation of the heart.
PRECAUTIONS
The Boston Scientific PTCA Guide Wires are designed to be compatible exclusively with the AddWire™ Extension Wire for catheter exchange. Do not use another extension system.
Guide wires should be used only by physicians thoroughly trained in the performance of PTCA.