MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW ULTRAFLEX IAB: 8FR 50CC; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	IPN038264
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A 50 ml iab (intra-aortic balloon) catheter was placed under fluoro guidance.The iabp console continued to give "helium loss" alarm due to the top portion of the balloon not inflating adequately.There was no blood in the helium line.It was exchanged for a second 40 ml iab catheter.The balloon tip again did not inflate adequately.Case was discussed with the arrow clinical rep via phone.Several maneuvers employed and the helium alarm continued.A third 40 ml iab catheter was placed, and it functioned properly with adequate inflation/deflation and augmentation.

• Brand Name: ARROW ULTRAFLEX IAB: 8FR 50CC
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 19816441
• Report Number: 19816441
• Device Sequence Number: 21027903
• Product Code: DSP
• UDI-Device Identifier: 10801902144192
• UDI-Public: (01)10801902144192
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/24/2024
• Report Date (Section F): 06/24/2024

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
• Operator of Device: Health Professional
• Device Model Number: IPN038264
• Device Catalogue Number: IAB-06850-U
• Device Lot Number: 18F23L0052
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/24/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 06/24/2024