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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Following a peripheral atherectomy procedure using a csi orbital atherectomy device (oad), an embolization occurred.On (b)(6) 2017, a peripheral atherectomy was performed using a csi oad.The target lesion was located in the proximal superficial femoral artery and was treated with the oad using eight passes followed by balloon angioplasty.The procedure was completed with no adverse events.On (b)(6) 2018, the patient presented with warmth in the left foot and an embolization was found to have occurred, resulting in amputation of the third toe.The cause of the embolization was unknown.
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