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Model Number IPN000260 |
Device Problems
Fracture (1260); Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/18/2020 |
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 the intra-aortic balloon (iab) was inserted into the patient's right femoral as the patient had hypertension.Within a couple of hours, the balloon had ruptured.As a result, the iab was removed and a new iab was inserted.There was no report of patient complications, serious injury or death.
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Event Description
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It was reported that the intra-aortic balloon (iab) was inserted into the patient's right femoral as the patient had hypertension.Within a couple of hours, the balloon had ruptured.As a result, the iab was removed and a new iab was inserted.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).No iab parts was returned to teleflex chelmsford for investigation.The reported complaint of iab leak suspected is not able to be confirmed.The root cause of the complaint is undetermined.The specific serial number/lot number was not reported, but a device history record (dhr) review was conducted for the lot numbers shipped to this account with no relevant findings.All devices passed 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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