The reported guide wire was received at csi for analysis.Visual examination confirmed that the guide wire was fractured.Scanning electron microscopy analysis identified evidence of heavy rotational grinding at the proximal fracture site.At the conclusion of the device analysis investigation, the report that the guide wire fractured was confirmed.It was hypothesized that the guide wire fractured due to excessive wear and possible fatigue from spinning under axial compression and/or in a tight bend, and a close distance between the driveshaft and guide wire, however this was not confirmed and the root cause of the fracture was unknown.The material inspection report for this guide wire lot number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Csi id: (b)(4).
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