The results of the investigation are inconclusive since the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.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 procedure, the guide wire in the diamondback peripheral orbital atherectomy device (oad) moved while the device was locked.The target lesion was diffusely diseased, calcified, and 90% stenosed located in the left anterior tibial artery.When the brake was fully activated on the oad, the guide wire continued to move through the device with little resistance.The guide wire was manually fixed into place, however the guide wire continued to pull back as the control knob of the oad was pulled back.The procedure was completed with balloon angioplasty, and the vessel had no residual stenosis at the end of the procedure.The patient was discharged without any complications.
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