(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the information reviewed, there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.
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It was reported that while removing the rx acculink stent delivery system (sds) from the protective hoop with no resistance reported, the stylet (distal mandrel) fell out of the hoop.The tip of the sds was mistaken as the stylet (distal mandrel) they pulled on it, realized it was the tip and thought they might have separated the tip or stent so they discarded the sds.There was no patient involvement.Another rx acculink was used to successfully complete the procedure.There was no reported clinically significant delay in the procedure.No additional information was provided.
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