MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW ULTRAFLEX; SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL

Model Number	IPN038075
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
After non complicated iabp (intra-aortic balloon pump) insertion, the balloon was viewed under fluoroscopy and found to only partially inflate.The distal part of the balloon did not unwind, and therefore did not inflate.Because of this malfunction, the iabp machine would not function due to a high-pressure warning.The defective balloon was removed, and after further clinical evaluation, provider decided not to replace it.Manufacturer response for system, balloon, intra-aortic and control, arrow (per site reporter) unknown.

• Brand Name: ARROW ULTRAFLEX
• Common Device Name: SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 19937471
• Report Number: 19937471
• Device Sequence Number: 17974916
• Product Code: DSP
• UDI-Device Identifier: 00801902136695
• UDI-Public: (01)00801902136695
• 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): 07/15/2024
• Report Date (Section F): 07/15/2024

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 Model Number: IPN038075
• Device Catalogue Number: IAB-06840-U
• Device Lot Number: 18F23K0028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2024
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2024
• 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: Female
• Date Report Sent to FDA: 07/15/2024