MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ULTRAFLEX IAB: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC

Catalog Number IAB-06850-U

Device Problem Inflation Problem (1310)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that "physician reported that the iab failed to unwrap upon insertion".As a result, the catheter was removed and a 2nd catheter from a different manufacturer.At the time of this report, the customer has not returned our requests for additional information.

Manufacturer Narrative

(b)(4).The reported complaint that the "iab failed to unwrap and iab fractured upon removal" is confirmed.During the investigation, the iabc central lumen was noted damaged and found no longer attached to the central lumen flex tip assembly.The damaged central lumen allowed blood to enter the helium pathway and can result in an inability of the iabc to inflate.The bladder was also noted damaged and punctured by the damaged central lumen.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 probable root cause of the complaint is undetermined.An investigation within teleflex was opened to address the issue.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "physician reported that the iab failed to unwrap upon insertion".As a result, the catheter was removed and a 2nd catheter from a different manufacturer.At the time of this report, the customer has not returned our requests for additional information.

• Brand Name: ULTRAFLEX IAB: 8FR 50CC
• 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: 19187645
• MDR Text Key: 341118343
• Report Number: 3010532612-2024-00313
• Device Sequence Number: 1
• Product Code: DSP
• UDI-Device Identifier: 10801902144192
• UDI-Public: 10801902144192
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2024

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-06850-U
• Device Lot Number: 18F23L0052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2023
• 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