(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The additional clip delivery system referenced is filed under a separate medwatch report number.
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Internal file number - (b)(4).Evaluation summary: all available information was investigated and the reported damaged steerable guide catheter (sgc) packaging was confirmed.A review of the lot history record revealed no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no similar incidents reported from this lot.All available information was investigated, and a definitive cause for the reported packaging tears, rips and holes cannot be determined, as it cannot be confirmed when the damage occurred.It is possible that the damage occurred during transit or at the account (storage/handling of the device prior to being delivered to the lab); however, this cannot be definitively confirmed.The observed packaging tear in the shelf carton appears to be due to the tear in the brown box.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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