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 material inspection report for this guidewire 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.Csi id: (b)(4).
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A viperwire guidewire and orbital atherectomy device (oad) were used for treatment of a severely calcified lesion in the anterior tibial artery via femoral antegrade approach.The vessel was not tortuous, and the diameter wsa 2.5mm.The lesion was a chronic total occlusion.The wire fractured during wire exchange prior to atherectomy.The physician was able to remove the wire tip with use of the catheter.A 4fr sheath was advanced over the wire fragment and catheter, and the sheath was retracted.Treatment was completed thereafter.
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