The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.A slight bend in the inner lumen was detected within the membrane near the iab tip approximately 1.8cm from the iab tip.However, no kinks were found on the iab catheter.A laboratory insertion test was unable to be performed due to the membrane being unfurled and a bend on the inner lumen.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.We are unable to confirm the reported difficulty during insertion because we are unable to mimic the clinical setting.A device and lot history record review was completed for the reported product.No non-conformances were found that are considered to be related to the event.(b)(4).
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