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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that the helium loss alarms occurred approximately every 30 minutes then to every "couple of minutes".It was noted that there was no blood in the tubing and the patient was actively moving and bending his leg.A leak test was performed and failed.As a result, md chose to continue the weaning process and the intra-aortic balloon (iab) was removed without issue or incident.There was no report of delay in therapy.There was no report of patient complication, serious injury or death.

Manufacturer Narrative

(b)(4).The product was not returned for investigation.The reported complaint of iab helium loss alarm 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 risk.This will be monitored for any developing trends.

Event Description

It was reported that the helium loss alarms occurred approximately every 30 minutes then to every "couple of minutes".It was noted that there was no blood in the tubing and the patient was actively moving and bending his leg.A leak test was performed and failed.As a result, md chose to continue the weaning process and the intra-aortic balloon (iab) was removed without issue or incident.There was no report of delay in therapy.There was no report of patient complication, 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: 12586320
• MDR Text Key: 275045595
• Report Number: 3010532612-2021-00296
• 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: 09/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2023
• Device Model Number: IPN000254
• Device Catalogue Number: IAB-05840-LWS
• Device Lot Number: 18F21D0024
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1