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

Model Number	SER18-150-25-220
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Hematoma (1884); Vascular Dissection (3160)
Date of Event	02/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The balloon catheter was used during an angioplasty procedure.The balloon was inserted into the patient and expanded to 10atm and burst.The balloon burst below the burst pressure (16atm) in a heavily calcified chronic total occlusion.When it burst, the vessel was ruptured.This lead to contrast extravasation, but no significant hematoma.The final run demonstrated it had settled, but will likely go down again.No further intervention was required with no patient sequelae.It was noted the vessel in question was initially completely occluded.
Additional Manufacturer Narrative
H3: the device was returned for analysis.Analysis confirmed the reported issue.A pinhole sized rupture was found near the proximal end of the balloon.
Event or Problem Description
Additional information received from the distributor indicated there was no patient harm.No procedure delay was reported.

• 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: 21551836
• Report Number: 3005994106-2025-00001
• Device Sequence Number: 4419737
• Product Code: LIT
• UDI-Device Identifier: 05391525784120
• UDI-Public: 05391525784120
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2026
• Device Model Number: SER18-150-25-220
• Device Lot Number: 22300892
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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: 03/07/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown