Model Number IPN000260 |
Device Problem
Fracture (1260)
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Patient Problems
Calcium Deposits/Calcification (1758); Death (1802)
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Event Date 03/16/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Other remarks: see mdr# 3010532612-2020-00093 ((b)(4)) and mdr# 3010532612-2020-00094 ((b)(4)) as the reports are related to the same patient.
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Event Description
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It was reported that the intra-aortic balloon (iab) was inserted into the patient and was noted by the staff that the balloon had ruptured.As a result, a second iab was used.There was a report of patient death.(b)(6) and nurses made the medical judgement that the device did not contribute to patient's death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in the helium pathway is confirmed.The iab bladder had a full thickness abrasion, which caused blood to enter the helium pathway.The appearance of the abraded area is consistent with repeated contact with calcified plaque on the aortic wall.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.Other remarks: see mdr# 3010532612-2020-00093 ((b)(4)) and mdr# 3010532612-2020-00094 ((b)(4)) as the reports are related to the same patient.
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Event Description
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It was reported that the intra-aortic balloon (iab) was inserted into the patient and was noted by the staff that the balloon had ruptured.As a result, a second iab was used.There was a report of patient death.Dr.(b)(6) and nurses made the medical judgement that the device did not contribute to patient's death.
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Search Alerts/Recalls
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