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Catalog Number 0684-00-0474 |
Device Problems
Partial Blockage (1065); Device Displays Incorrect Message (2591)
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Patient Problem
Myocardial Infarction (1969)
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Event Date 05/29/2018 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).Product status: the product has been returned to the manufacturer, but is pending investigation.Once the investigation is completed a supplemental report with our findings will be submitted.(b)(4).
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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, after working normally for about 19 hours, an alarm reading "check iab catheter" was generated.The customer checked the catheter carefully but, nothing was found and the alarm persisted.The iab was removed and blood clots were found in the balloon.Indication for use was stemi(st elevation myocardial infarction), heart failure.There was no reported injury to the patient.
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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 the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the catheter but it was not a maquet product.The extender tubing was also returned.Dried blood was found occluding the inner lumen.The occlusion was unable to be cleared.An underwater leak test of the balloon, catheter, y-fitting, extracorporeal and extender tubing was performed and five leaks were detected on the membrane (1) approximately 1.5cm, (2, 3, 4 and 5) approximately between 22.1cm and 22.4cm from the rear seal measuring (1) 0.1cm, (2) 0.18cm, (3) 0.13cm and (4 and 5) 0.1cm in length.The evaluation confirms the reported alarm, check iab catheter & leak, blood in tubing problem.The reported alarm, check iab catheter and blood in tubing problems were most likely triggered by leaks which were found on the membrane.Under magnification, a whitish patch was observed around the leak on the proximal side of the membrane.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.The penetrations found on the distal side of the membrane appear to have been caused by a sharp object.We were unable to determine when the penetrations occurred.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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Event Description
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It was reported that during intra-aortic balloon (iab) therapy, after working normally for about 19 hours, an alarm reading "check iab catheter" was generated.The customer checked the catheter carefully but, nothing was found and the alarm persisted.The iab was removed and blood clots were found in the balloon.Indication for use was stemi(st elevation myocardial infarction), heart failure.There was no reported injury to the patient.
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Search Alerts/Recalls
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