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

Model Number	SER18-135-60-100
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The balloon catheter was used during a percutaneous transluminal angioplasty (pta) procedure.The balloon was placed in tight venous stenosis in the subclavian.It was reported the balloon would not deflate after being overinflated to 18 atm.It was noted the rated burst pressure (rbp) for this balloon model is 16 atm.The site reportedly using "full contrast." the physician used ultrasound guidance to puncture the balloon with a needle.The physician was able to fully remove the balloon without issue.There was no reported procedure delay or patient harm.

• Brand Name: ADVANCE SERENITY¿ 18
• Common Device Name: Catheter, angioplasty, peripheral, transluminal
• 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: 23417260
• Report Number: 3005994106-2025-00016
• Device Sequence Number: 15685699
• Product Code: LIT
• UDI-Device Identifier: 05391525787152
• UDI-Public: 05391525787152
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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: SER18-135-60-100
• Device Catalogue Number: G59797
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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