MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 40CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06840-U

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2023

Event Type  malfunction  

Event Description

It was reported that "after catheter inserted, an alarm for helium leakage of 3 was displayed.After repeated inspections, there was no result, and the machine had to be stopped and interrupted.After removal, it was found that there was gas leakage at the tail end of the catheter".A 2nd catheter was not inserted.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4) , other remarks: n/a, corrected data: n/a.

Event Description

It was reported that "after catheter inserted, an alarm for helium leakage of 3 was displayed.After repeated inspections, there was no result, and the machine had to be stopped and interrupted.After removal, it was found that there was gas leakage at the tail end of the catheter".A 2nd catheter was not inserted.No patient harm or injury.The patient status is reported as "fine".

Manufacturer Narrative

(b)(4).The reported complaint for iab helium loss alarm is confirmed.During the investigation, a puncture consistent with contact from a sharp object was found on the iab bladder.The bladder leak can allow blood to enter the helium pathway and it would cause helium loss alarms.No other leaks were detected during functional testing.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met during the complaint investigation due to the bladder leak.The root cause of the bladder leak is undetermined.The most probable potential cause of how the catheter came into contact with a sharp object is customer handling.No further action required at this time.This will be monitored for any developing trends.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: ULTRAFLEX IAB: 7.5FR 40CC
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18477342
• MDR Text Key: 332456130
• Report Number: 3010532612-2024-00037
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23F0014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2023
• Initial Date FDA Received: 01/09/2024
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Male