The reported oad was returned for analysis with the guide wire engaged in the device.Analysis of the handle revealed the saline sheath, driveshaft, and engaged guide wire to have been destructively cut.All cut sections exhibited adhered dried biological material.The cut and deformed driveshaft and guide wire sections are the result of the surgical intervention performed to remove the device from the patient.Further examination revealed the oad crown and guide wire spring tip to be intact and undamaged.When tested, the device functioned as intended with no abnormalities observed.There was no damage observed with the oad or guide wire sections that would have contributed to the reported event.The device history record for this oad 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 dissection was noted.The target lesion was 60% stenosed and located in the distal superficial femoral artery (sfa).The lesion was treated using one pass with the oad at low speed and one pass at medium speed.Following the second pass with the oad, a dissection was noted and the oad became stuck in the patient.Surgery was performed to resolve the dissection and remove the oad, and the patient was stable following the procedure.
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