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

Lot Number	18F23A0004
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Iabp balloon popped during the procedure.

• Brand Name: ARROW FIBEROPTIX IAB INTRA-AORTIC BALLOON CATHETER
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): ARROW INTERNATIONAL / ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED); morrisville NC 27560
• MDR Report Key: 18139872
• Report Number: MW5148128
• Device Sequence Number: 7016208
• Product Code: DSP
• UDI-Device Identifier: 10801902167733
• UDI-Public: 1 0801902 16773 3
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/16/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2024
• Device Lot Number: 18F23A0004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Life Threatening
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 65 KG
• Patient Ethnicity: Hispanic
• Patient Race: White