Catalog Number IAB-05840-LWS |
Device Problems
Difficult to Remove (1528); Material Rupture (1546)
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Patient Problems
Vessel Or Plaque, Device Embedded In (1204); Injury (2348)
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Event Date 03/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Uf/importer report #(b)(4).
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Event Description
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Event description: intra-aortic balloon pump (iabp) straw colored fluid noted to be accumulating in dependent loop of helium line just prior to where line enters pump.No fluid or blood noted in line at or near patient access site.The pump alarmed and it was noted that the balloon on the pump had ruptured.A cardiologist attempted to remove the pump emergently at bedside, however was unable to successfully withdraw the pump.Patient was taken to surgery for retrieval of intra-aortic balloon.Intra-aortic balloon pump removed under direct visualization.What was original intended procedure: patient had an intra-aortic balloon pump place (via right femoral access), for management of severe coronary artery disease.Checked: required intervention to prevent permanent impairment/damage.
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Manufacturer Narrative
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(b)(4) received the device for analysis.The reported complaint of removal difficulty is confirmed.The iab was returned with the sheath pulled over the bladder and the bladder was found torn.The damaged is consistent with removal difficulty.Dried blood was found on the interior of the iab bladder membrane as a result of a puncture consistent with contact from the broken fiber near the distal tip of the iab.The root cause of the broken fiber is undetermined.A device history record (dhr) review was conducted with no relevant findings.The device passed all manufacturing specifications prior to release.(b)(4) assessed the risk for the reported complaint and there are no new or revised risks.This reported issue will be monitored for any developing trends.(b)(4).
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Event Description
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Event description: intra-aortic balloon pump (iabp) straw colored fluid noted to be accumulating in dependent loop of helium line just prior to where line enters pump.No fluid or blood noted in line at or near patient access site.The pump alarmed and it was noted that the balloon on the pump had ruptured.A cardiologist attempted to remove the pump emergently at bedside, however was unable to successfully withdraw the pump.Patient was taken to surgery for retrieval of intra-aortic balloon.Intra-aortic balloon pump removed under direct visualization.What was original intended procedure: patient had an intra-aortic balloon pump place (via right femoral access), for management of severe coronary artery disease.Checked: required intervention to prevent permanent impairment/damage.
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Search Alerts/Recalls
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