Updated sections: a4, b4, g4, g7, h2, h3, h6, h10.The product was returned with the membrane completely unfolded and blood found on the exterior of the catheter.One kink was found on the catheter tubing near the y-fitting approximately 75.4cm from the iab tip.The optical fiber was found to broken at this location.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 evaluation determined a kink in the catheter and optical fiber break.It is difficult to determine when or how a kink in the catheter and optical fiber break occurs.Although we did not repeat the event in the laboratory setting, a kink in the catheter can cause inflation difficulty or an alarm.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.Complaint record # (b)(4).
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