Model Number IPN000257 |
Device Problem
Material Rupture (1546)
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Patient Problem
Death (1802)
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Event Date 02/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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It was reported that 10 minutes after insertion of the intra-aortic balloon (iab), the staff noted that the iab had ruptured.As a result, the iab was removed and a second iab was inserted.There was a report of patient death.Rich botto (manager of cath lab) confirmed that the device did not contribute to patient's death.
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Event Description
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It was reported that 10 minutes after insertion of the intra-aortic balloon (iab), the staff noted that the iab had ruptured.As a result, the iab was removed and a second iab was inserted.There was a report of patient death.(b)(6) (manager of cath lab) confirmed that the device did not contribute to patient's death.
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Manufacturer Narrative
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Qn#: (b)(4).Teleflex received the device for investigation.The reported complaint of iabc blood in helium pathway is confirmed.A break in the central lumen was noted near the proximal end of the iab catheter, which can cause blood to enter the helium pathway.The root cause of the broken central lumen is undetermined.A potential cause is user handling during catheter insertion.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.Teleflex assessed the risk for the reported complaint.There are no new or revived risk.This will be monitored for any developing trends.
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Search Alerts/Recalls
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