Frontline Guide Wires

Prescriptive Information

Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.

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Indications

Boston Scientific ChoICE PT, PT Graphix, ChoICE, Luge, and Mailman Guide Wires 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. Boston Scientific PT2 and IQ Guide Wires are intended to facilitate the placement of balloon dilatation catheters or other interventional therapeutic devices during PTCA, PTA, or other intravascular interventional procedures. They are not intended for use in the cerebral vasculature.

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Contraindications

None known.

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Warnings

Contents supplied sterile using 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. When the guide wire is in the body, it should be manipulated only under fluoroscopy. Do not attempt to move the wire without observing the resultant tip response. Never advance the guide wire against resistance without first determining the reason for resistance under fluoroscopy. Excessive force against resistance may result in separation of the guide wire tip, damage to the catheter or vessel damage. The hydrophilic coating of these guide wires increases the possibility of vessel wall perforation compared to non-hydrophilic coatings. Maintain diligent control of the distal tip at all times during an intervention to avoid vessel dissections and perforations.

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Precautions

Prescription only. Federal law (USA) restricts this device to sale by or on the order of a physician. Guide wires should be used only by physicians thoroughly trained in their intended use.

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Potential Adverse Effects

Abrupt closure • Allergic reaction to contrast media • Angina or unstable angina • Arrhythmias • Cardiac tamponade / pericardial effusion Contrast induced renal insufficiency or renal failure • Death • Embolism • Hemorrhage or hematoma • Infection, local infection, systemic infection Myocardial infarction or ischemia • Pain at the access site • Pseudoaneurysm • Stroke / cerebral vascular accident (CVA) / transient ischemic attack (TIA) Vascular thrombus • Vessel spasm • Vessel trauma (dissection, perforation, rupture or injury)

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