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/INDICATION FOR USE
The Magic Torque guidewire facilitates placement of a catheter during diagnostic or interventional procedures. The wire can be torqued to facilitate navigation through tortuous arteries and/or avoid unwanted side branches.
Not intended for use in coronary arteries.
• This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional procedures.
• Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated.
• If contrast agents are used, use extreme caution in patients who have had a severe reaction to contrast agents and who cannot be adequately premedicated.
Potential adverse events which may result from the use of the device include but are not limited to:
• Air Embolism/Thromboembolism
• Allergic Reaction
• Arteriovenous (AV) Fistula
• Infection or Sepsis/Infection
• Myocardial Ischemia and/or Infarction
• Stroke (CVA)/Transient Ischemic Attacks (TIA)
• Vessel Occlusion
• Vessel Perforation, Dissection, Trauma, or Damage
• Vessel Spasm
• Wire Entrapment/Entanglement
• Foreign Body/Wire Fracture