The product was returned with the membrane completely unfolded and blood on the exterior of the catheter with the one-way valve attached.The sheath was not returned for evaluation.A kink was found on the catheter tubing approximately 70.9cm from the iab tip.Additionally a second kink was found on the catheter tubing and inner lumen near the y-fitting approximately 66.3cm from the iab tip.The one-way valve was vacuum tested and it held vacuum a laboratory insertion test was unable to be performed due to the membrane being unfurled and the catheter tubing and inner lumen kinked.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and no leaks were detected.A leak may impact the ability to maintain vacuum.The condition of the iab as received indicated a kink on the catheter tubing and inner lumen.A kink in the inner lumen can cause difficulty during insertion.We are unable to determine when the kink may have occurred.The evaluation confirmed the reported problem.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 complaint trend data for the period may-19 to apr-21 was reviewed.There were no triggers identified for the review period.Communication/interviews were performed to obtain all possible information.Reference complaint #(b)(4).
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