|
Model Number IPN000257 |
Device Problem
Deformation Due to Compressive Stress (2889)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/21/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that the intra-aortic balloon (iab) counterpulsation catheter was inserted during operation.It was found that the front end of the iab was damaged and could not be used normally.As a result, the iab was replaced.There was no report of patient complications, serious injury or death.
|
|
Manufacturer Narrative
|
(b)(4).Teleflex received the device for investigation.The reported complaint iab catheter damaged is confirmed.The iabc central lumen was noted damaged/broken in the distal tip area upon receipt of the sample.A damaged/broken central lumen can result in difficulty of insertion and/or a helium pathway leak.The iabc bladder membrane was fully intact, with no leaks noted.Additionally, an exposed retention tube was noted upon return (from the packaging tray).No other damage was noted, and it could not be determined what caused the retention tube to move.A potential cause of the moved retention tube is a result of customer handling.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 revived risk.This will be monitored for any developing trends.
|
|
Event Description
|
It was reported that the intra-aortic balloon (iab) counterpulsation catheter was inserted during operation.It was found that the front end of the iab was damaged and could not be used normally.As a result, the iab was replaced.There was no report of patient complications, serious injury or death.
|
|
Search Alerts/Recalls
|
|
|