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

Catalog Number IAB-06840-U

Device Problem Break (1069)

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

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "after using a catheter for coronary heart disease, the machine frequently alarms "3" for a large amount of helium leakage.After removing the catheter and conducting an in vitro experiment, the central cavity was broken".As a result, a 2nd catheter was inserted at the same insertion site.No patient harm or injury.The patient status is reported as "fine".

Event Description

It was reported that "after using a catheter for coronary heart disease, the machine frequently alarms "3" for a large amount of helium leakage.After removing the catheter and conducting an in vitro experiment, the central cavity was broken".As a result, a 2nd catheter was inserted at the same insertion site.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, the intra-aortic balloon catheter (iabc) central lumen was noted broken near the iabc distal tip, which can result in helium loss alarms.The returned iabc bladder membrane was fully intact, with no leaks noted.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 broken central lumen.The root cause of the broken central lumen is undetermined.A corrective and preventive action has been initiated to further investigate the issue.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: 18469153
• MDR Text Key: 332904429
• Report Number: 3010532612-2024-00030
• 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: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• 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: 18F23D0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2023
• 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