CHOICE™ Extra Support 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.

INTENDED USE/INDICATIONS FOR USE

Boston Scientific ChoICE, ChoICE PT, Luge, Mailman and PT Graphix Guidewires, and Boston Scientific ChoICE Magnet, ChoICE PT Magnet, Luge Magnet, Mailman Magnet, and PT Graphix Magnet 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.

CONTRAINDICATIONS

  • None known.

WARNINGS

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. Excessive force against resistance may result in separation of the guidewire tip, damage to the catheter or vessel damage. Resulting guidewire fractures might require additional percutaneous intervention or surgery. The hydrophilic coating of these guidewires increases the possibility of vessel wall perforation compared to non-hydrophilic coatings. Care should be taken when advancing a guidewire after stent deployment. A guidewire may exit between stent struts when recrossing a stent that is not fully apposed to the vessel wall. Subsequent advancement of any device over the guidewire could cause entanglement between the guidewire and the stent.

PRECAUTIONS

Carefully check and match therapeutic device compatibility to the wire prior to use. Sharp insertion tools may compromise the integrity of the polymer coating. To avoid guidewire damage and possible shearing of plastic, do not withdraw or manipulate the wire through a metal needle cannula. Excessive tightening of the torque device onto the wire may result in abrasion of the coating on the wire.

Boston Scientific guidewires (DFU 90976970) are designed to be compatible exclusively with the AddWire™

Extension Wire for interventional device exchange. Do not use another extension or exchange system. Carefully check and match the compatibility of the guidewire diameter with the interventional device prior to use. These guidewires should only be used in devices having an inner lumen diameter greater than 0.015 in (0.39 mm).

Boston Scientific Magnet guidewires (DFU 90976935) should only be used in devices having an inner lumen diameter greater than 0.015 in (0.39 mm). NOTE THAT THE ACTUAL DIAMETER MAY BE UP TO 0.015 IN (0.39MM) IN THE MAGNET EXCHANGE SEGMENT OF 182 CM guidewires. Compatibility of the therapeutic device with the 182 cm guidewire and The MAGNET Exchange Device should be verified prior to use to ensure holding force adequate to keep wire from moving during exchange.

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.

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