MAUDE Adverse Event Report: CREAGH MEDICAL ADVANCE SERENITY¿ 18; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	SER18-135-50-20
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: device analysis confirmed the reported issue.The device was returned in two segments.The distal section of the balloon (approx.60% of the balloon length), the distal tip, and both marker bands were not received.
Event or Problem Description
The balloon catheter was used during an arteriovenous fistula angioplasty procedure.The balloon was used during radial access of the cephalic vein.The balloon broke during inflation.The shaft was partially detached.It was noted the stenosis created a "dog-bone" effect.The physician reportedly waited for the balloon to fully deflate before pinning/pulling off the guidewire.The degree of stenosis was noted to be 70-80%.The procedure was considered successful.No additional procedures were required.Additional information was requested, but was provided at the time of this report.
Event or Problem Description
Additional information received from the distributor indicated the balloon was prepared per the ifu.There was no indication of damage to the device prior to use.A vacuum was no held on the balloon during loading of the device to the target lesion.The site denied torquing or twisting the device during the procedure.There was no calcification present in the target vessel, but there was venous narrowing.The length of the lesion was approximately 2mm.The reported issue occurred mid procedure upon initial inflation.The procedure successfully completed with another balloon.The reported issue resulted in a procedure delay of approximately two minutes.The procedure was carried out with no complications or medical intervention.The patient left the site in good condition.
Additional Manufacturer Narrative
H6: impact code (f) updated.Fda code 2199 no longer applies.

• 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: 21562232
• Report Number: 3005994106-2025-00002
• Device Sequence Number: 14560636
• Product Code: LIT
• UDI-Device Identifier: 05391525787039
• UDI-Public: 05391525787039
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2025

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
• Device Expiration Date: 03/07/2026
• Device Model Number: SER18-135-50-20
• Device Lot Number: 22300343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 04/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2023
• 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: Female