ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC
|
Back to Search Results |
|
Catalog Number IAB-05840-LWS |
Device Problem
Entrapment of Device (1212)
|
Patient Problem
Device Embedded In Tissue or Plaque (3165)
|
Event Date 10/19/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported by the cardiology fellow that was assisting with the removal of the intra-aortic balloon (iab).The fellow stated that they were attempting a planned removal of the iab.They were pulling the catheter and the sheath together as recommended.He pulled the catheter until it engaged the sheath, and then pulled them together.The sheath was fully removed, but they could not get the tail of the iab to come out.They attempted to manually withdraw air from the balloon with a syringe and were able to pull back 10cc before getting resistance.They were still unable to remove at this point.They called the hotline to discuss any further action prior to surgically removing the iab.As a result, the doctor stated that they are going to proceed with surgical removal.They were able to successfully remove the iab surgically.There were no other complications or injuries to the patient, and the patient is doing well in the icu.The iab was discarded in the or, and they could not see any report of a clot or kinking to the balloon.
|
|
Manufacturer Narrative
|
(b)(4).Teleflex did not receive the device for investigation therefore the reported complaint of iab removal difficulty is not able to be confirmed.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 revised risks.The reported complaint will be monitored for any developing trends.No further action required at this time.
|
|
Event Description
|
It was reported by the cardiology fellow that was assisting with the removal of the intra-aortic balloon (iab).The fellow stated that they were attempting a planned removal of the iab.They were pulling the catheter and the sheath together as recommended.He pulled the catheter until it engaged the sheath, and then pulled them together.The sheath was fully removed, but they could not get the tail of the iab to come out.They attempted to manually withdraw air from the balloon with a syringe and were able to pull back 10cc before getting resistance.They were still unable to remove at this point.They called the hotline to discuss any further action prior to surgically removing the iab.As a result, the doctor stated that they are going to proceed with surgical removal.They were able to successfully remove the iab surgically.There were no other complications or injuries to the patient, and the patient is doing well in the icu.The iab was discarded in the or, and they could not see any report of a clot or kinking to the balloon.
|
|
Search Alerts/Recalls
|
|
|