Catalog Number 0684-00-0567 |
Device Problems
Failure to Advance (2524); Difficult to Advance (2920)
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Patient Problem
Death (1802)
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Event Date 03/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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 initial start up of intra-aortic balloon (iab) therapy, the customer emergently tried to insert an iab catheter on the or table and it would not advance through the sheath.The patient subsequently expired; however, the death is not attributed to the device.
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Event Description
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It was reported that during initial start up of intra-aortic balloon (iab) therapy, the customer emergently tried to insert an iab catheter on the or table and it would not advance through the sheath.The patient subsequently expired; however, the death is not attributed to the device.
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Manufacturer Narrative
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The product was returned with the membrane completely unfolded and blood on the exterior of the catheter and between the catheter and the sheath.The returned sheath was over the membrane and partially covering the distal end of the catheter.A laboratory insertion test was unable to be performed due to the membrane being unfurled.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 of the returned condition of the catheter and we are unable to mimic the clinical setting.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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Search Alerts/Recalls
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