SAFARI²™ Preshaped TAVR TAVI Guidewire

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 “Instructions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The SAFARI²™ Guidewire is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within transcatheter aortic valve procedures.

CONTRAINDICATIONS

This wire is not intended for use in the cerebrovasculature or coronary arteries.

WARNINGS

• The SAFARI² Guidewire should be used only by physicians trained in the introduction and placement of interventional devices including those used within transcatheter aortic valve procedures.
• Carefully read all instructions prior to use. Observe all warnings and precautions. Failure to do so may result in complications.
• Prior to use, inspect for damage. If damaged, DO NOT USE.
• Monitor wire position throughout the procedure for proper placement of curve and distal tip.
• Do not torque this guidewire.
• Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated.
• Inserting the distal end of the guidewire through a Tuohy-Borst Adapter may result in damage to the tip of the guidewire.
• 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.
• When advancing or removing the guidewire, always use fluoroscopic guidance with radiographic equipment that provides high-resolution images. Never position the guidewire blindly, as this may result in misplacement, dissection or perforation.
• Exercise care in handling of the guidewire during a procedure to reduce the possibility of accidental breakage, bending, kinking, or coil separation. Resulting guidewire fractures might require additional percutaneous intervention or surgery.
• Never advance the guidewire against the resistance without first determining the reason for resistance under fluoroscopy. Excessive force against resistance may result in damage to the catheter or vessel/organ. Care should be taken when advancing a guidewire after device deployment.
• The wire should only be introduced into or withdrawn from the ventricle through a catheter already positioned in the ventricle.
• The curve of the SAFARI² Guidewire should be constrained within a catheter during insertion into or withdrawal from the body or treatment site.
• The SAFARI² Guidewire is manufactured with a double curve; attempts to modify may alter its performance. Alterations to curve may lead to complications including Perforation or Dissection, Mitral Valve Regurgitation, Pericardial Effusion, Cardiac Tamponade, Cardiac Arrest and Guidewire Replacement.
• Clinical data showing use of this device in pregnant/breastfeeding women is not available.
  

ADVERSE EVENTS

• Access site complication
• Additional Surgical Procedure
• Air Embolism/Thromboembolism
• Allergic Reaction
• Amputation
• Aorta Complications
• Arteriovenous (AV) Fistula
• Arrhythmia
• Bleeding
• Cardiac and/or Septal Perforation
• Death
• Embolism
• Hematoma
• Hemorrhage
• Hemoglobinuria
• Hypovolemia
• Infection or Sepsis
• MACCE
• Myocardial Ischemia and/or Infarction
• Pericardial Effusion
• Pseudoaneurysm
• Renal Failure or Injury
• Stroke or other Neurologic event
• Tamponade
• Thrombus
• Valve Complications
• Vascular Complication
• Vessel Occlusion
• Vessel Perforation, Dissection, Trauma, or Damage
• Vessel Spasm
• Wire Entrapment/Entanglement
• Foreign Body/Wire Fracture