Catalog Number IAB-05840-LWS |
Device Problem
Entrapment of Device (1212)
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Patient Problem
Vascular Dissection (3160)
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Event Date 12/23/2017 |
Event Type
Injury
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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 upon removal of the intra-aortic balloon (iab) it was noticed that the catheter was stuck.The md pulled on the catheter and the patient suffered a femoral tear.The patient was operated on and he is currently doing fine.Once the balloon was removed, it was noticed that inside the balloon was foreign substances.Medical intervention was required to repair the femoral tear.There was no reported patient death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of removal difficulty is confirmed.The iab was returned with a damaged bladder consistent with removal difficulty.During the investigation, blood was confirmed within the iab helium pathway.The blood found within the bladder membrane could have potentially led to removal difficulties through entrapment.Due to the damaged state of the iab upon return, the original cause of the leak was unable to be determined.The root cause of how blood entered the helium pathway is undetermined.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.Teleflex assessed the risk for the reported complaint.There are no new or revised risks.This will be monitored for developing trends.No further action at this time.
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Event Description
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It was reported that upon removal of the intra-aortic balloon (iab) it was noticed that the catheter was stuck.The md pulled on the catheter and the patient suffered a femoral tear.The patient was operated on and he is currently doing fine.Once the balloon was removed, it was noticed that inside the balloon was foreign substances.Medical intervention was required to repair the femoral tear.There was no reported patient death.
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Search Alerts/Recalls
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