Fracture of Guidewires

The guidewire is wrapped around a predefined cylindrical fixture.  Once removed the guidewire is examined for visible signs of fracture

Test Procedure

The distal end of the guidewire is fixed by inserting into the hole in the cylindrical former (of torquer).

The guidewire is secured by holding while doing the first turn. The guidewire is tightly wound around the former holding the guidewire tight. The guidewire is wound at least 8 times (8 complete turns). A reduced number of turns can be used with appropriate risk-based clinical justification.

The guidewire is then unwrapped and examined for fracture caused by the procedure. Any fracture occurring in the region of fixation or in the first turn is disregarded.

Test is performed at room temperature.

Equipment

  • Predefined fixture – torquer
  • Microscope – visual inspection only

Measured Parameters

  • Pass/Fail signs of fracture after unwrapping

Scope

  • Any interventional guidewires
  • 035 guidewires
  • 014-018 guidewires
  • Interventional neuroradiological guidewires

 

Service Levels

Applicable Standards

  • ISO 11070:2014
    Sterile single-use intravascular introducers, dilators and guidewires

Related Tests

OLE2209

Guidewire Fracture Standard fixture - Insertion of the guidewire into the hole

Guidewire Fracture Standard fixture - Insertion of the guidewire into the hole

Guidewire Fracture Standard fixture - Insertion of the guidewire into the hole

Guidewire Fracture Standard fixture - Insertion of the guidewire into the hole

Guidewire Fracture Standard fixture - Damaged wire

Guidewire Fracture Standard fixture - Damaged wire


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