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

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 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.

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

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

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

CONTRAINDICATIONS

The guidewire is not intended for use in the cerebral vasculature or coronary arteries.

WARNINGS

• The SAFARI² Extra Support guidewire should be used only by physicians trained in the introduction and placement of interventional devices including those used within transcatheter aortic valve procedures. 
• Guidewire stiffness should be considered. Carefully read labelling to ensure selection of correct guidewire stiffness and SAFARI2 Extra Support curve dimensions. 
• Do not torque this guidewire. 
• Inserting the distal end of the guidewire through a Tuohy-Borst Adapter without using the J-straightener will result in damage to the tip of the guidewire. 
• 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. 
• 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 guidewire should only be introduced into or withdrawn from the heart through a catheter already positioned in the ventricle. 
• The SAFARI² Extra Support guidewire is manufactured with a pre-formed double curve; attemps to modify the double curve may alter its performance and/or compromise coating integrity. Alterations to curve may lead to complications including perforation or dissection, mitral valve regurgitation, pericardial effusion, cardiac tamponade, cardiac arrest and guidewire replacement. 
• This device contains nickel. Persons with allergic reaction to this metal may have an allergic reaction.  
• Manipulation, advancement, and/or withdrawal past sharp or beveled edges may result in destruction and/or separation of the outer coating, which may lead to clinical adverse events, resulting in coating material remaining in the vasculature or device damage. 
• Use appropriate anticoagulation to prevent or reduce device thrombosis, as this device has not been tested in the absence of anticoagulation.

PRECAUTIONS

• The safety and effectiveness of this guidewire for temporary pacing in the ventricle has not been established.

ADVERSE EVENTS

• Access site complication (pseudoaneurysm, hematoma, AV fistula) 
• Additional surgical/endovascular procedure 
• Allergic reaction/anaphylaxis 
• Amputation 
• Arrhythmia 
• Bleeding (hemorrhage, hematoma) 
• Cardiac damage and/or septal perforation 
• Death 
• Device related thrombus 
• Embolism (air, thrombus, plaque, device fragments) 
• Guidewire entrapment/entanglement 
• Hemoglobinuria 
• Hypovolemia 
• Infection or sepsis 
• Myocardial ischemia and/or infarction 
• Pericardial effusion or cardiac tamponade 
• Renal failure or injury 
• Stroke (cerebral infarction), TIA or other neurologic event 
• Vessel occlusion, perforation, dissection, trauma, spasm or damage