MAUDE Adverse Event Report: CREAGH MEDICAL ADVANCE SERENITY¿ 18; Catheter, angioplasty, peripheral, transluminal

Model Number	SER18-150-20-80
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The balloon catheter was used to treat a chronic total occlusion (cto) in the left popliteal (pt) artery.The balloon ruptured during the second inflation at 8atm.There was no patient impact or harm.The distributor indicated the device was prepped per ifu.A popliteal intervention procedure was being performed.The vessel calcification was reported to be moderate with 70% stenosis and a lesion length of 70mm.The procedure was completed with another balloon of equal size.No medical intervention was required.The patient was in good condition.

• Brand Name: ADVANCE SERENITY¿ 18
• 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: 19281875
• Report Number: 3005994106-2024-00006
• Device Sequence Number: 6338777
• Product Code: LIT
• UDI-Device Identifier: 05391525784007
• UDI-Public: 05391525784007
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K180007
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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: 10/15/2025
• Device Model Number: SER18-150-20-80
• Device Lot Number: 22202391
• 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: 04/16/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2022
• 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: Male