MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 7.5FR 30CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06830-U

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/25/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that "after using the catheter, there were repeated alarms of helium leakage in the morning.Adjusting the equipment and catheter could not solve the problem.After replacing the catheter, the problem was resolved".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 the catheter, there were repeated alarms of helium leakage in the morning.Adjusting the equipment and catheter could not solve the problem.After replacing the catheter, the problem was resolved".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 of iab helium loss alarm is confirmed based on visual inspection of the returned sample.The customer returned a 30cc 7.5fr ultraflex intra-aortic balloon catheter (iabc) without the original packaging for investigation.Upon return, the iabc central lumen was found damaged and broken near the distal tip, which can result in helium loss alarms.The device was returned cut in multiple areas and in 2 separate sections.The functional testing of the iabc was unable to be performed due to the returned state of the device.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 damaged catheter.The root cause of the complaint could not be determined due to the returned state of the device.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a, corrected data: n/a.

• Brand Name: ULTRAFLEX IAB: 7.5FR 30CC
• 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: bryanna connelly ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 18469170
• MDR Text Key: 332904485
• Report Number: 3010532612-2024-00031
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902003751
• UDI-Public: 00801902003751
• 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
• 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-06830-U
• Device Lot Number: 18F23H0009
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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: 66 YR
• Patient Sex: Female
• Patient Weight: 115 KG