Model Number IPN000257 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Death (1802)
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Event Date 09/15/2020 |
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 when the cardiac surgeon tried to implant the intra-aortic balloon (iab), it was noted that the balloon detached from the catheter during insertion.As a result, the iab was replaced.It was later reported that the patient deceased.Dr (b)(6) stated that there were no complications caused by the defected iab.The defected device hadn't been inserted fully inside the patient.
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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: balloon damaged 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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Event Description
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It was reported that when the cardiac surgeon tried to implant the intra-aortic balloon (iab), it was noted that the balloon detached from the catheter during insertion.As a result, the iab was replaced.It was later reported that the patient deceased.Dr latifa hernisa stated that there were no complications caused by the defected iab.The defected device hadn't been inserted fully inside the patient.
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Event Description
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It was reported that when the cardiac surgeon tried to implant the intra-aortic balloon (iab), it was noted that the balloon detached from the catheter during insertion.As a result, the iab was replaced.It was later reported that the patient deceased.Dr (b)(6) stated that there were no complications caused by the defected iab.The defected device hadn't been inserted fully inside the patient.
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Manufacturer Narrative
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Qn#(b)(4).Teleflex received the device for investigation.The reported complaint of iab balloon damaged is not confirmed.The returned iabc bladder was fully intact.No problems were noted during the functional testing.The returned catheter passed functional test specifications.The root cause of the complaint is undetermined.A device history record (dhr) review was conducted for the lot number of the returned sample 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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Search Alerts/Recalls
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