The reported guide wire was received at csi for analysis, without the spring tip.Follow-up attempts confirmed that the spring tip had been shipped with the guide wire, but upon receipt it could not be located.A visual examination confirmed that the spring tip fractured near the proximal solder bond.Scanning electron analysis could not conclusively determine the cause of the fracture due to the secondary damage found on the faces of the support ribbon and core wire fracture faces.There was possible fatigue identified on the support coil, however this could not be confirmed.The support coil was not elongated, which indicated the guide wire was not pulled to fracture.At the conclusion of the device analysis investigation, the report that the guide wire fractured was confirmed, however the root cause of the fractured was undetermined.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.Patient age is between 70 and 75 years old.Csi id: (b)(4).
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