INDICATIONS, SAFETY, AND WARNINGS X-Pedion™ Hydrophilic Guidewire

INDICATIONS FOR USE

The 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.

CAUTION

  • Federal (USA) law 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.

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 or 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.

COMPATIbility

The guidewire is compatible with other ancillary products used in intravascular procedures. Any over-the-wire style of micro catheter used with the guidewire should have at least 0.004” (0.1 mm) clearance between the lumen of catheter and the guidewire.

POTENTIAL COMPLICATIONS

Procedures requiring percutaneous catheter introduction should not be attempted by physicians unfamiliar with the possible complications, which may occur during or after the procedure. 

Possible complications include, but are not limited, to the following:

  • complication of radiation exposure (e.g., alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia)
  • ischemia
  • infection
  • perforation of vessel or arterial wall
  • puncture site hematoma
  • thrombus formation
  • vasospasm

WARNINGS

  • This device is intended for single use only. Discard the product after use. 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.
See the device manual for detailed information regarding the instructions for your, indications, contraindications, warnings, precautions, and potential adverse events.

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INSTRUCTIONS FOR USE (IFU) 

 

View full instructions for use.

X-PEDION IFU (PDF)