MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INCORPORATED) ARROW IAB; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number IAB-0-8850-U

Device Problems Defective Device (2588); Activation Failure (3270)

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

Event Date 06/14/2023

Event Type  malfunction  

Event Description

Multiple iabp failures all had the same error (restriction alarm).When the iabp is removed, each balloon had a tightly furled distal third that could not unwrap.Prior to removal from the packing, the iab instructions are to pull negative on the iab.This was done in the procedures.The rep was engaged during the most recent issue and the rep could not identify the issue.Three iabs are being sent or have been sent to the vendor.Reference reports: mw5118512, mw5118513.

• Brand Name: ARROW IAB
• Type of Device: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INCORPORATED)
• MDR Report Key: 17182601
• MDR Text Key: 317791719
• Report Number: MW5118511
• 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: 06/15/2023

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 Model Number: IAB-0-8850-U
• Device Lot Number: 18F23005F821BC30169F8132
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2023
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White