The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.The inner lumen was found occluded with dried blood.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.The iab was placed on the cs300 pump and the iab fully inflated.No alarm sounded from the pump.The reported event cannot be confirmed by the evaluation.A non-conforming material report 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 oct-2019 to sep-2021 was reviewed.Communication/interviews: (4111/213) communication/interviews were performed to obtain all possible information.Reference complaint #: (b)(4).
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