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Model Number IPN000257 |
Device Problem
Deformation Due to Compressive Stress (2889)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/03/2021 |
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 the during the intraoperative examination, it was noted that the balloon was damaged.As a result, a new intra-aortic balloon (iab) was inserted at the same insertion site.There was no report of patient complications, serious injury or death.
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Manufacturer Narrative
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Qn# (b)(4).Teleflex received the device for investigation.The reported complaint iab catheter damaged is confirmed.During the investigation, the iabc central lumen was noted damaged/broken in the flex tip assembly area, which can cause blood to enter the helium pathway.The iabc bladder membrane was fully intact, with no leaks noted.The root cause of the complaint 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 revised risk.This will be monitored for any developing trends.
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Event Description
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It was reported that the during the intraoperative examination, it was noted that the balloon was damaged.As a result, a new intra-aortic balloon (iab) was inserted at the same insertion site.There was no report of patient complications, serious injury or death.
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Search Alerts/Recalls
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