The product was not returned to abbott vascular for analysis.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 and/or complaints reported from this lot.The investigation was unable to determine a conclusive cause for the reported packaging damage and sterility issue.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that during unpacking of a 3.50x28mm xience sierra, the foil pouch was noted without any damages, however, the inside clear tyvek pouch was noted with a hole in it.There were no damages noted to the chipboard box.The device was not used and there was no patient involvement.Another device was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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