Trackwise#: (b)(4).The device was returned to the factory for evaluation on 06/02/2022.An investigation was conducted on 12/06/2022.Photographs were provided by the account.A photographic inspection was conducted.A visual inspection was conducted.Signs of clinical use and evidence of blood was observed on the base of the aortic cutter.The aortic cutter was in a deployed state.There were no visual defects observed on the cutter.The housing case was observed to be split in half at the base of the aortic cutter.Based on the returned condition of device as well as the investigation results, the reported failure "break" was confirmed.The certificate of conformance (c of c) was reviewed.The vendor certifies that this device lot conforms to all applicable product specifications.The lot #25161785 history record review was completed.There were no ncmrs, rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the reported failure.Specific actions for the reported/analyzed failure mode are being maintained and documented under maquet's corrective and preventive action (capa) system.
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