(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Visual inspection was performed on the returned device.The reported complaint was confirmed.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 of the reported lot revealed no similar incidents.The investigation determined the loose material in the sealed header bag appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
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It was reported that during inspection for consignment return products, a small, white, crescent shaped foreign material was found inside the sterile pouch of the of the absolute pro vascular self expanding stent system (sess).Reportedly, the device was sealed and had not been opened.The device was not used and there was no patient involvement.No additional information was provided.Returned device analysis identified the foreign material as a potential manufacturing component.
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