(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for evaluation.Visual inspection was performed and the reported kinked shaft and irregular appearance were confirmed.The irregular texture was unable to be confirmed due to the returned condition of the device.The inner member was bunched and separated.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation determined the reported/noted difficulties of irregular appearance, shaft kink, inner member separation and inner member bunching appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that upon loading the 2.5x18 mm xience alpine stent delivery system (sds) on the guide wire, it was noted that the midshaft did not look right and it did not feel right; irregular appearance and irregular feel.The midshaft was not stretched or separated.However, there was a slight kink on the shaft.The device did not enter the patient anatomy.An unspecified sds was used to complete the procedure.There were no adverse patient effects and no reported clinically significant delay in the procedure.Returned device analysis found that the inner member was separated.No additional information was provided.
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