MAUDE Adverse Event Report: ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED) ARROW TELEFLEX ULTRAFLEX IAB (INTRA-AORTIC BALLOON) 8F; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Catalog Number IAB-06850-U

Device Problems Inflation Problem (1310); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2023

Event Type  malfunction  

Event Description

Teleflex 50cc iab( intra-aortic balloon) placed via right groin.Post procedure fluoro revealed that the iab balloon was not fully inflating.This balloon was removed.Teleflex balloon outside the body revealed that the balloon material remained wrapped at the proximal and distal ends, and was in fact not fully expanding despite proper functioning of the console.

• Brand Name: ARROW TELEFLEX ULTRAFLEX IAB (INTRA-AORTIC BALLOON) 8F
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED)
• MDR Report Key: 16993990
• MDR Text Key: 315937267
• Report Number: MW5117790
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/19/2023

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-06850-U
• Device Lot Number: 18F23C0015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/23/2023
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Male