Model Number IPN000260 |
Device Problem
Material Deformation (2976)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Qn#: (b)(4).
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Event Description
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It was reported that at the time of insertion, it was noted that there was a kink at the proximal end of the intra-aortic balloon (iab) and so the iab could not be used.As a result, a new iab was used.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 at the time of insertion, it was noted that there was a kink at the proximal end of the intra-aortic balloon (iab) and so the iab could not be used.As a result, a new iab was used.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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(b)(4).No parts were returned to teleflex chelmsford for investigation.The reported complaint of iab kinked is not able to be confirmed.If the product is returned at a later date, a full investigation of the sample will be completed.The root cause of the complaint is undetermined.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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Manufacturer Narrative
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(b)(4).Teleflex received the device for investigation.The reported compliant of iab kinked is confirmed.A kink to the central lumen was noted during the functional testing of the returned iabc, and resistance was noted at the location of the kink upon loading a guidewire into the iabc central lumen.The root cause of the kinks is undetermined, but a potential cause is customer handling.Additionally, the original packaging tray was noted with damage to the "arrow" packaging sticker which retains the iabc bladder in the packaging tray.This damage indicates the iabc was not prepped correctly per the ifu and can result in damage to the iabc.An in-service has been requested to reiterate the instructions for use (ifu), including the appropriate method for iabc prep/removal from its packaging.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 at the time of insertion, it was noted that there was a kink at the proximal end of the intra-aortic balloon (iab) and so the iab could not be used.As a result, a new iab was used.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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