Catalog Number IAB-S840C |
Device Problem
Difficult to Advance (2920)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/23/2017 |
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 on a patient of 177cm in height after puncture, the spring wire guide (swg) could not pass through the catheter therefore the intra-aortic balloon was not inserted.The catheter was replaced with a new one.Patient outcome: fine.There was no reported death or patient complications.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint of "swg can't pass through the catheter" is confirmed.The iab was returned with the packaging tray arrow sticker missing/damaged, which indicates the iab was not prepped correctly per the ifu.The iab was noted with damage consistent with not being prepped successfully.The iab central lumen was noted kinked and bent which caused guidewire insertion difficulty.The cause of the complaint is a result of improper prep per the ifu.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 revised risks.
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Event Description
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It was reported that on a patient of 177cm in height after puncture, the spring wire guide (swg) could not pass through the catheter therefore the intra-aortic balloon was not inserted.The catheter was replaced with a new one.Patient outcome: fine.There was no reported death or patient complications.
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Search Alerts/Recalls
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