MAUDE Adverse Event Report: CREAGH MEDICAL FIRST CHOICE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	UHP7574
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 e1 (hcp, dist): the balloon catheter was used during a percutaneous transluminal angioplasty (pta) procedure.The site reported the initial balloon ruptured in a calcified area.The procedure was completed with the use of another balloon.There was no patient harm.No procedure delay was reported.
Event or Problem Description
Additional information received from the distributor indicated the target vessel had no calcification with approximately 80% stenosis.The lesion length was not provided.It was confirmed the balloon ruptured during initial inflation to 14atm inside of a stent.There was no patient harm.The event resulted in a procedure delay of approximately 5 minutes.No further medical intervention was required and the patient was in stable condition.Patient information was provided.

• Brand Name: FIRST CHOICE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CREAGH MEDICAL; ida business park; creagh road; ballinasloe, co. galway H53 K 8P4; EI H53 K8P4
• Manufacturer (Section G): CREAGH MEDICAL; ida business park; creagh road; 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: 19183197
• Report Number: 3005994106-2024-00004
• Device Sequence Number: 15240752
• Product Code: LIT
• UDI-Device Identifier: 08570590020051
• UDI-Public: 08570590020051
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K102645
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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 Expiration Date: 10/08/2025
• Device Model Number: UHP7574
• Device Lot Number: 22202370
• 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: 04/03/2024
• Supplement Date Received by Manufacturer: 05/13/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 53 YR
• Patient Sex: Male
• Patient Weight: 109 KG