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

Model Number	SER18-135-60-100
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The balloon catheter was used during an angioplasty procedure.The physician was unable to retract the balloon into the procedural sheath.The reported issue resulted in additional radiation exposure to the patient and the use of alternative means to remove the balloon.The balloon was able to be removed by snaring from a second vascular access site.There was no further patient impact or procedure delay reported.
Additional Manufacturer Narrative
H3: device evaluation had not yet begun, but was anticipated.A supplemental mdr will be completed following analysis completion.
Additional Manufacturer Narrative
H3: the balloon was returned for analysis.Analysis confirmed the reported issue.The distal end of the balloon was partly bunched.There was evidence of necking at the proximal end of the balloon and the proximal marker band has been moved proximally along the inner shaft.The entire length of the balloon had increased from specification by approximately 5.6 cm.The balloon failed to inflate during testing due to narrowing of the outer shaft.H11: this report is submitted beyond the 30-day timeframe due to administrative delay in linking the completed analysis to the original mdr.

• 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: 21778495
• Report Number: 3005994106-2025-00003
• Device Sequence Number: 18109905
• Product Code: LIT
• UDI-Device Identifier: 05391525787152
• UDI-Public: 05391525787152
• 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): 07/16/2025

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: 03/06/2026
• Device Model Number: SER18-135-60-100
• Device Lot Number: 22300284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 04/04/2025
• Supplement Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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