Documentation

Axessio Peripheral Microguidewire

Axessio Peripheral Microguidewire IFU

Axessio™ Guidewire is intended for use in diagnostic and interventional procedures, to facilitate the introduction and placement of interventional devices.

Read all instructions prior to use. To avoid complications, observe all warnings and precautions found in the complete device labeling and instructions for use.

Axessio™ is a trademark of Accurate Medical Therapeutics Ltd.

Trademarks are the property of their respective owners and are used herein solely for informational purposes.

Illustrations for information purposes - not indicative of actual size or clinical outcome. Any performance specifications are believed to be reliable and are the sole responsibility of the legal manufacturer Brivant Ltd.

CAUTION: Federal law restricts this device to sale by or on the order of a Physician in which the practitioner practices to use or order the use of the device.

Indications for Use: Axessio Guidewires are intended for use in the coronary and peripheral vasculature.

Contraindications: The Axessio Guidewire is not intended for use in the cerebral vasculature.Patients judged not acceptable for percutaneous intervention (PCI).

Warnings: • A guidewire is a delicate instrument and must not be advanced, withdrawn, or torqued if resistance is met. Excessive force against resistance may result in separation of the guidewire tip, damage to the catheter or vessel perforation.•Guidewire manipulations must always be observed under fluoroscopy to observe resultant tip response. If the guidewire is removed and is to be re-inserted, it must be inspected for signs of damage (weakened or kinked segments) prior to re-introduction. Do not re-introduce if guidewire is weakened or kinked.• Reuse of single-use devices creates a potential risk of patient or user infections. Contamination of the device may lead to injury, illness or death of the patient.• Cleaning, disinfection and sterilization after use may compromise essential material and design characteristics leading to device failure.

Precautions: • Failure to follow the instructions may compromise guidewire performance and result in complications.• Inspect guidewire prior to use for any surface irregularities, bends or kinks. Damaged and/or irregular guidewires should not be used.•To avoid guidewire damage, do not withdraw the wire through a metal needle cannula.• Neither the guidewire insertion tool nor torque device are intended to enter the body.• Check labeled diameter of diagnostic or therapeutic catheter and verify compatibility with the guidewire diameter prior to use.

GU05220068