Back-up Meier™ Steerable Guidewire

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a licensed practitioner. Prior to use, please refer to all applicable “Instructions for Use” for more information on Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The Back-up Meier Steerable Guidewire facilitates catheter placement and exchange during diagnostic or interventional procedures, including abdominal aortic aneurysm (AAA) endovascular graft procedures.

Not intended for use in coronary arteries.

CONTRAINDICATIONS

• Heavily tortuous vessels
• Previous diagnosis of severe vasospasm

WARNINGS

• The Back-up Meier Steerable Guidewire is not intended for use in the neuro vasculature.
• Carefully read all instructions prior to use of this product. Observe all warnings and precautions, failure to do so may result in complications.
• 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 an allergic 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 or move the guidewire without observing the resultant tip response, as this may result in misplacement, vessel trauma or patient injuries.
• While the guidewire is in the body do not advance the movable core if the tip is in a curved shape. Never twist or force the core because excessive force may cause it to penetrate the coil resulting in vessel trauma or other patient injuries.
• Never advance, withdraw and/or rotate the guidewire against resistance without first determining the reason for resistance under fluoroscopy. Do not rotate the guidewire if significant resistance is felt. Excessive force against resistance may result in separation of the guidewire tip, damage to the catheter or vessel trauma and other patient injuries.
• Never attempt to straighten a J-tipped or C-tipped guidewire within a patient by advancing the movable core once it has been withdrawn, this can cause vessel trauma or other patient injuries.
• 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.
• Exercise caution when using the guidewire during intracardiac procedures (e.g. valve replacement) to avoid cardiac trauma including valvular insufficiency, organ perforation or cardiac tamponade.
• Exercise care in handling of the guidewire during a procedure to reduce the possibility of breakage, bending, kinking, or coil separation. Do not use a guidewire that has been damaged.
• The tip of the guidewire is not designed to be reshaped. Reshaping of the tip could result in damage to the guidewire.

PRECAUTIONS

• Use the device prior to the “Use By” date noted on the package.
• Remove the guidewire carefully from the carrier tube to reduce the possibility of damage to the distal tip.
• Sharp insertion tools may compromise the integrity of the coating. To avoid guidewire damage and possible shearing of the coating, do not advance, withdraw or manipulate the wire through a metal cannula needle.
• If the coils of a guidewire separate, DO NOT REMOVE THE CORE. Carefully remove the coils and core simultaneously. Retain the wire and contact customer service for product return instructions.

POTENTIAL ADVERSE EVENTS

Potential adverse events which may result from the use of the device when used as indicated include but are not limited to:

• Allergic reaction (contrast, device or other)
• Cardiac Tamponade
• Cardiac Trauma
• Cerebral Vascular Accident (CVA)/Transient Ischemic Attack (TIA)
• Death
• Embolism (air, device, plaque, thrombus, tissue, or other)
• Hematoma
• Hemorrhage
• Infection/Sepsis
• Myocardial Ischemia/Infarction
• Need for additional intervention or surgery
• Pericardial Effusion
• Renal Insufficiency or Renal Failure
• Thrombosis/Thrombus
• Vasospasm
• Vessel Occlusion
• Vessel Trauma (Arteriovenous (AV) Fistula, Dissection, Perforation, Pseudoaneurysm, Rupture, or Injury)