MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Model Number IPN000254

Device Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the intra-aortic balloon (iab) was in use the staff experienced persistent helium loss 3 alarms after patient arrival to the cticu.The ekg has a large temp pacing spike and intra-aortic balloon pump (iabp) is showing arrhythmia detected with patient in nsr.Lead score also poor, and partial obstruction noted on bpw.After changing lead placement and decreasing and eventually d/c of temp pacer, no additional helium loss alarms.Repositioning patient also improved bpw.No blood noted in gas line.The iab was removed after successful weaning, no additional alarms prior to removal.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 helium loss alarm is not confirmed.The returned iabc bladder was fully intact.No alarms were noted during the functional testing.The returned catheter passed functional test specifications.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 revived risk.This will be monitored for any developing trends.

Event Description

It was reported that when the intra-aortic balloon (iab) was in use the staff experienced persistent helium loss 3 alarms after patient arrival to the cticu.The ekg has a large temp pacing spike and intra-aortic balloon pump (iabp) is showing arrhythmia detected with patient in nsr.Lead score also poor, and partial obstruction noted on bpw.After changing lead placement and decreasing and eventually d/c of temp pacer, no additional helium loss alarms.Repositioning patient also improved bpw.No blood noted in gas line.The iab was removed after successful weaning, no additional alarms prior to removal.There was no report of patient complications, serious injury or death.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11414365
• MDR Text Key: 234900289
• Report Number: 3010532612-2021-00051
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902007247
• UDI-Public: 00801902007247
• Combination Product (y/n): N
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F20J0041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2021
• Date Manufacturer Received: 04/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1