Model Number IPN000263 |
Device Problem
Failure to Advance (2524)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/29/2020 |
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 during insertion, the staff found the intra-aortic balloon (iab) was defective as it did not pass through the guidewire.As a result, the user used a new iab and inserted the iab using the same insertion site to complete the procedure.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported complaint that the "iab catheter was found defective as it did not pass through the guidewire" is confirmed.The returned intra-aortic balloon catheter (iabc) central lumen was found kinked and resistance was noted upon passing the guidewire through the iabc central lumen.The root cause of the kinked central lumen is undetermined.A potential cause is customer handling.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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Event Description
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It was reported that during insertion, the staff found the intra-aortic balloon (iab) was defective as it did not pass through the guidewire.As a result, the user used a new iab and inserted the iab using the same insertion site to complete the procedure.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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