|
Model Number IPN000260 |
Device Problem
Unraveled Material (1664)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/23/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that the balloon of the intra-aortic balloon (iab) was opened before removing the stylet and was difficult to pass.As a result, a new iab was used.There was no report of patient complications, serious injury or death.
|
|
Event Description
|
It was reported that the balloon of the intra-aortic balloon (iab) was opened before removing the stylet and was difficult to pass.As a result, a new iab was used.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 unwrapped prematurely 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 will result in difficulty of maintaining a vacuum on the iabc bladder.If a vacuum on the bladder is not maintained, it can result in a bladder to unwrap prematurely.The iabc bladder membrane passed functional testing.The root cause of the complaint is undetermined, but 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.
|
|
Search Alerts/Recalls
|
|
|