ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC
|
Back to Search Results |
|
Model Number IPN000254 |
Device Problems
Fluid/Blood Leak (1250); Material Rupture (1546)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 06/22/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(4).
|
|
Event Description
|
It was reported that the intra-aortic balloon (iab) was placed in the patient and immediately, the staff noticed blood inside the iab helium tubing.As a result, they staff exchanged the iab out for another iab.There was no report of patient complications, serious injury or death.
|
|
Event Description
|
It was reported that the intra-aortic balloon (iab) was placed in the patient and immediately, the staff noticed blood inside the iab helium tubing.As a result, they staff exchanged the iab out for another iab.There was no report of patient complications, serious injury or death.
|
|
Manufacturer Narrative
|
(b)(4).Teleflex received the device for investigation.The reported complaint of iab blood in helium pathway is confirmed.A puncture to the bladder, consistent with contact from the broken fiber, was found near the distal tip of the catheter which allowed blood to enter the helium pathway.The root cause of the broken fiber 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.
|
|
Search Alerts/Recalls
|
|
|