Catalog Number IAB-S840C |
Device Problem
Inflation Problem (1310)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 01/10/2019 |
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 the intra-aortic balloon (iab) catheter was inserted, it was noted that there was no counter-pulsation and the balloon could not inflate.As a result, the catheter was replaced with a new catheter via the opposite insertion site and a second attempt at the procedure was made successfully.There was no report of patient complication or serious injury and death.
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Event Description
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It was reported that the intra-aortic balloon (iab) catheter was inserted, it was noted that there was no counter-pulsation and the balloon could not inflate.As a result, the catheter was replaced with a new catheter via the opposite insertion site and a second attempt at the procedure was made successfully.There was no report of patient complication or serious injury and death.
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Manufacturer Narrative
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(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab would not inflate completely is not able to be confirmed.The root cause of the complaint is undetermined.If the product is returned at a later date, a full investigation of the sample will be completed.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.The reported complaint will be monitored for any developing trends.No further action required at this time.
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Search Alerts/Recalls
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