Catalog Number 0684-00-0605 |
Device Problem
Backflow (1064)
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Patient Problem
Calcium Deposits/Calcification (1758)
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Event Date 05/19/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).The device has not been returned to the manufacturer so we are unable to complete an evaluation.If provided we will send a supplemental report with our additional findings.Complaint # (b)(4), record # (b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy on an ami (acute myocardial infarction) patient a blood back run in the catheter tube was noted.The iab was replaced to continue therapy.Moderate sclerosis, calcification, and tortuosity were noted in the patient vessel.No patient injury was reported.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded and blood on the interior and exterior of the catheter.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 11.7cm from the rear seal measuring 0.064cm in length.The reported problem was most likely triggered by a leak which was found on the membrane.The penetration found on the membrane appears to have been caused by a sharp object.The evaluation confirmed the reported problem.We are unable to determine when this 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.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy on an ami (acute myocardial infarction) patient a blood back run in the catheter tube was noted.The iab was replaced to continue therapy.Moderate sclerosis, calcification, and tortuosity were noted in the patient vessel.No patient injury was reported.
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Search Alerts/Recalls
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