MAUDE Adverse Event Report: CREAGH MEDICAL LTD. FIRST CHOICE; EUHP75124

Model Number	UHP75124
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The balloon catheter was used for a percutaneous transluminal angioplasty (pta) procedure.The site reported the balloon broke while inside the patient.The provided image and video clip confirmed the balloon catheter separated mid-balloon.The distal segment contained the tip, marker band, part of the inner lumen, and part of the balloon.No segments remained in the patient.The procedure was completed with the use of another balloon.There was no patient injury.The site was queried for additional information without receiving a response.

• Brand Name: FIRST CHOICE
• Common Device Name: EUHP75124
• Manufacturer (Section D): CREAGH MEDICAL LTD.; ida business park; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL LTD.; ida business park; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer Contact: phil haney ; 7905 golden triangle drive suite 190; eden prairie, MN 55344 ; 9525007598
• MDR Report Key: 23045758
• Report Number: 3005994106-2025-00010
• Device Sequence Number: 18557462
• Product Code: LIT
• UDI-Device Identifier: 08570590020242
• UDI-Public: 08570590020242
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K143561
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/12/2025

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: UHP75124
• Device Lot Number: 22402209
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2025
• Initial Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown