Catalog Number IAB-05840-LWS |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Death (1802)
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Event Date 04/09/2016 |
Event Type
Death
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Manufacturer Narrative
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(b)(4).Sample will not be returned for evaluation.
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Event Description
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It was reported that while in the cath lab the md inserted an intra-aortic balloon (iab) via the right femoral artery.A competitor's introducer sheath was used due to the recall.One hour after the patient was transported to the intensive care unit multiple alarms were noted with blood coming into the lumen.The device was removed and not replaced.There was not another attempt to reinsert the catheter.There was a complication listed as a delay/ interruption in therapy.The patient expired.
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Manufacturer Narrative
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(b)(4) no product was returned for evaluation.A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings.The device passed all manufacturing specifications prior to release.Conclusion: the reported complaint of blood in the helium pathway is not able to be confirmed.No product was returned for evaluation.The root cause of the complaint is undetermined.
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Event Description
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It was reported that while in the cath lab the md inserted an intra-aortic balloon (iab) via the right femoral artery.A competitor's introducer sheath was used due to the recall.One hour after the patient was transported to the intensive care unit multiple alarms were noted with blood coming into the lumen.The device was removed and not replaced.There was not another attempt to reinsert the catheter.There was a complication listed as a delay/ interruption in therapy.The patient expired.
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Search Alerts/Recalls
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