The reported guide wire was received for analysis.Examination of the guide wire revealed the proximal core wire to be fractured.The distal spring tip section revealed the distal and proximal solder bonds to be intact and undamaged, while the spring tip coils were noted to be damaged and deformed.There was no adhered biological material on the guide wire shaft or spring tip.There was no other damage revealed with the guide wire that would have contributed to the reported event.Scanning electron microscopy revealed the presence of torsional stresses on the fracture face of the core wire.At the conclusion of the device analysis investigation, the root cause of the guide wire fracture and if it contributed to the reported perforation was unable to be confirmed.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.(b)(4).
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During a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), a perforation occurred and the guide wire was damaged.The target lesion was located in the popliteal artery and was treating using one pass with the oad at low speed, one pass at medium speed and one pass at high speed.Balloon angioplasty was performed following treatment with the oad, and a perforation was noted above the location of the guide wire.Pressure was applied to the exterior of the leg, and the perforation resolved with no additional intervention.When the guide wire was removed from the patient, the tip was noted to be frayed.Upon examination by the hospital staff, the tip of the wire became detached outside the patient.The patient was stable following the procedure.
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