50342-001

Indications, Safety, and WarningsCaution

Federal law (USA) restricts this device to use by or under the direction of a physician.

This device should be used only by physicians with a thorough understanding of angiography and percutaneous interventional radiologic procedures.

Indications for useThe X-pedion™ - 10 Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.Contraindications

The X-pedion™ - 10 Hydrophilic Guidewire is not indicated for use in the coronary vessels.

Precautions

Prior to use, carefully examine the guidewire and its packaging to verify no damage has occurred during shipment. Do not use if pouch is open or damaged.

Inspect the guidewire for any surface irregularities, bends or kinks. Any guidewire damage may decrease the desired performance characteristics. Avoid exposure of the guidewire coating to disinfection agents such as alcohols. This may result in coating delamination.

The hydrophilic coating bonded to the guidewire is an extremely lubricious surface when properly hydrated. Ensure proper hydration by allowing entire guidewire to become wet for at least 30 seconds prior to use.

Neither the guidewire introducer nor the torque device are intended to enter the body.

To prevent damage to the guidewire coating, manipulate the guidewire using the torque device at proximal end of the guidewire.

Operators should take all necessary precautions to limit x-radiation doses to patients and themselves by using sufficient shielding, reducing fluoroscopy times, and modifying X-ray technical factors where possible.

Potential complicationsPotential complications of the device and the procedure include or are synonymous with, but may not be limited to:

Access site complications such as hematoma, pain, hemorrhage, nerve damage

Adverse reactions to antiplatelet/anticoagulation agents, contrast media, or anesthesia such as aspiration, hypersensitivity, hypotension

Cardiac complications such as arrhythmia

Complications of radiation exposure such as alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia

Device complications such as device fracture, friction, foreign body in patient

Hematologic complications such as thrombosis, thromboembolism, hemolysis, intracranial hemorrhage

Neurological deficits including emotional changes, stroke and ischemia

Systemic complications such as fever, infection, inflammation, edema, shock, toxicity, foreign body reaction, organ failure, hypertension

Therapeutic response decreased

Vascular complications such as dissection, perforation, rupture, vasospasm, stenosis, necrosis, fistula, embolism

Death

*Consult instructions for use for other therapy devices and medications for additional potential complication information. If a serious incident related to the device occurs, contact your Medtronic representative and the competent authority in your respective country/region.Warnings

This device is intended for single use only. Do not reprocess or re-sterilize. Reprocessing and re-sterilization increase the risks of patient infection and compromised device performance. Structural integrity and/or function may be impaired through reuse or cleaning.

Never advance or withdraw the guidewire against resistance until the cause of the resistance is determined by fluoroscopy. Do not attempt to move the guidewire without observing the resultant tip response.

Visually inspect all sterile barrier systems, that are labeled as sterile, immediately prior to use. Do not use the device if breaches in sterile barrier system integrity are evident.

Nickel (CAS 7440-02-0) is a tested material and/or substance that can cause sensitization or an allergic reactions in some patients.

For additional Materials of Concerns information such as REACH, CA Prop 65 or other product stewardship programs, go to www.medtronic.com/productstewardship

Indications, contraindications, warnings, and instructions for use can be found in the product labeling supplied with each device or viewed at www.medtronic.com/manualsUS-NNP-2400083 (v1.0)

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Customer Care Team