The product was returned with the membrane completely unfolded with traces of blood on the exterior and interior of the catheter.The sheath, extender tubing and pressure tubing were also returned.No physical damage noted.An underwater leak test of the balloon, y-fitting, catheter tubing, extracorporeal tubing, extender tubing and pressure tubing was performed and a leak was detected on the membrane at approximately 16.26cm from the iab rear seal and measuring approximately 0.11cm in length.The evaluation confirmed the reported leak, which appears to have been caused by a sharp object.However, we are unable to determine when this may have occurred.A device and lot history record review was completed for the reported product.No nonconformances were found that are considered to be related to the event.Analysis of production (3331/213) - the device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the review results, it was determined that there is no relation between the manufacturing process and the reported failure.Historical data analysis (4109/213) - the review of the historical data was performed.Trend analysis (4110/213) - the overall complaint trend data for the period apr-19 through mar-21 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
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