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

Catalog Number IAB-06840-U

Device Problem Inflation Problem (1310)

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

Event Date 03/08/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "balloon not complete inflate." additional information received reports "the baloon was not able to inflate completely becasue some part of the wrap".The catheter was removed and was not replaced.There were another attempt to the procedure and it was successful therapy was not delayed or interrupted no patient harm or injury.It was reported the patient's current condition is "stable and recovering".

Manufacturer Narrative

(b)(4).The product was not returned for investigation.The customer provided a photo for evaluation.The photo showed the intra-aortic balloon catheter (iabc) with the proximal portion of the bladder noted as twisted.This is consistent with the reported event.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.The reported complaint of iab would not inflate completely is confirmed based on the photo provided by the customer.In the photo, the proximal portion of the intra-aortic balloon catheter (iabc) bladder was noted twisted, which can result in the inability of the iabc to fully inflate or unwrap.The product was not returned for investigation.Based on a review of the device history record (dhr), the product met specification upon release; however, the specifications were not met due to the twisted bladder.The probable root cause of the complaint is manufacturing related.A corrective and preventive action has been initiated to address the issue.

Event Description

It was reported "balloon not complete inflate." additional information received reports "the balloon was not able to inflate completely because some part of the wrap".The catheter was removed and was not replaced.There were another attempt to the procedure and it was successful therapy was not delayed or interrupted no patient harm or injury.It was reported the patient's current condition is "stable and recovering".

• Brand Name: ARROW 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: taliah shabazz ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 19216447
• MDR Text Key: 341467368
• Report Number: 3010532612-2024-00283
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 00801902026804
• UDI-Public: 00801902026804
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K000729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23F0015
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 46 YR
• Patient Sex: Female
• Patient Weight: 90 KG