Catalog Number 0684-00-0434 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Code Available (3191)
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Event Date 03/24/2018 |
Event Type
Injury
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Manufacturer Narrative
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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 the iab ruptured while in situ 2 days post-insertion.The console was turned off immediately and clamped.The iab was then removed 25 minutes post-rupture.The health impact to the patient is reported to be premature cessation of mechanical support, which may cause unknown longer term complications related to renal/distal limb complications as the patient is still in acute phase.
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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 intra-aortic balloon (iab) therapy the iab ruptured while in situ 2 days post-insertion.The console was turned off immediately and clamped.The iab was then removed 25 minutes post-rupture.The health impact to the patient is reported to be premature cessation of mechanical support, which may cause unknown longer term complications related to renal/distal limb complications as the patient is still in acute phase.
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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 and between the catheter and the sheath.The sensor cable was cut from the iab and not returned.An underwater leak test of the balloon, catheter, y-fitting and extracorporeal tubing was performed and one leak was detected on the membrane approximately 1cm from the rear seal measuring 0.025cm in length.The reported problems was most likely triggered by a leak which was found on the membrane.Under magnification, a whitish patch was observed around the leak.This whitish patch is the typical appearance of an abrasion mark which is caused by calcified plaque in the aorta.The evaluation confirmed the reported problem.An abrasion leak is a known inherent risk and common failure mode caused by calcified plaque in the aorta.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 the iab ruptured while in situ 2 days post-insertion.The console was turned off immediately and clamped.The iab was then removed 25 minutes post-rupture.The health impact to the patient is reported to be premature cessation of mechanical support, which may cause unknown longer term complications related to renal/distal limb complications as the patient is still in acute phase.
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Search Alerts/Recalls
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