It was reported that during intra-aortic balloon (iab) therapy, the console generated a catheter restriction alarm.Soon after the alarm, blood was seen in the helium tubing.The catheter was then removed from the patient.The physician who performed the iab insertion claims to have encountered tortuosity while inserting the catheter.There was no reported injury to the patient.
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Updated sections: b4, g4, g7, h2, h3, h6, h10.The product was returned with the membrane completely unfolded and blood was observed on the interior and exterior of the catheter.The extracorporeal, extender and pressure tubing were also returned.Two kinks were observed on the catheter tubing at 70.4 cm and 76.5 cm from the iab tip.In underwater leak test of the balloon, catheter, inner lumen, y-fitting, extracorporeal, extender and pressure tubing was performed and one leak was detected on the membrane approximately 1.28 cm from the rear seal measuring 0.19 cm in length.The technician then attempted to insert a laboratory 0.025¿ guide wire through the inner lumen of the returned iab and found slight traces of blood.The inner lumen was able to be cleared.The reported problem was most likely triggered by a leak which was found on the membrane.The penetration found in the membrane appears to have been caused by a sharp object.We are unable to determine when the penetration may have occurred.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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It was reported that during intra-aortic balloon (iab) therapy, the console generated a catheter restriction alarm.Soon after the alarm, blood was seen in the helium tubing.The catheter was then removed from the patient.The physician who performed the iab insertion claims to have encountered tortuosity while inserting the catheter.There was no reported injury to the patient.
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