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 - Damaged wire

ViVitro Labs Advantages

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