Additional initial reporter & e-mail address: (b)(6).Device evaluation: the product was returned with the membrane completely unfolded and blood on the exterior of the catheter.No kinks were observed on the iab catheter.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 pumped for two hours which represents one complete autofill cycle.The iab pumped normally and 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.The device history records review concluded that there were no ncmrs, rework, or deviations documented for the reported lot/serial number.Based on the dhr/lhr review results, it was determined that there is no relation between the manufacturing process and the reported failure.The review of the historical data indicates that no other similar complaint was reported for the same lot/serial number and reported failure mode.The overall 24 month product complaint trend data for the period jul-2019 and jan-2021 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Complaint record id # (b)(4).
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