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Meier™ Guidewire

Indications, Safety, and Warnings

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

CONTRAINDICATIONS

• Heavily tortuous vessels

• Previous diagnosis of severe vessel spasm

WARNINGS

• Use extreme caution and careful judgment in patients for whom anticoagulation is not indicated.

PRECAUTIONS

• Precautions to prevent or reduce clotting should be taken when any catheter is used:

A. Consider the use of systemic heparinization.

B. Flush or rinse all products entering the vascular system with sterile isotonic saline or a similar solution prior to use.

• The physician should be familiar with and experienced in standard techniques of percutaneous transluminal angioplasty and knowledgeable of the current medical literature concerning the complications of angioplasty.

ADVERSE EVENTS

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

• Air Embolism/Thromboembolism

• Allergic Reaction

• Amputation

• Arteriovenous (AV) Fistula

• Death

• Embolism

• Hematoma

• Hemorrhage

• Hemoglobinuria

• Infection or Sepsis/Infection

• Myocardial Ischemia and/or Infarction

• Pseudoaneurysm

• Stroke (CVA)/Transient Ischemic Attacks (TIA)

• Thrombus

• Vessel Occlusion

• Vessel Perforation, Dissection, Trauma, or Damage

• Vessel Spasm

• Wire Entrapment/Entanglement

• Foreign Body/Wire Fracture

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