MAUDE Adverse Event Report: CREAGH MEDICAL SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER; Catheter, angioplasty, peripheral, transluminal

Model Number	SRA-DC18-20080
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The site reported the balloon catheter broke in the patient's body prior to inflation.No further information was provided.Additional information was requested.The balloon catheter shaft broke proximal to the rapid exchange (rx) port.The issue occurred after the first inflation.After deflation, the catheter was advanced further distally, through the lesion and calcification.It was noted resistance was felt.It was at this time, the shaft broke.The complete balloon catheter was able to be removed.The issue happened at the conclusion of the procedure.The sublime balloon was used after other balloons could no cross the lesion.The physician was unable to recross the lesion with a guidewire upon balloon removal.This was where the procedure concluded.There was no patient harm or procedure delay due to the shaft break.
Additional Manufacturer Narrative
H3: the balloon was returned for analysis.Analysis confirmed the reported issue.The balloon was received in two segments.The fracture was just proximal to the rapid exchange (rx) port.There was also a kink in the catheter near the strain relief.

• Brand Name: SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER
• 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
• MDR Report Key: 22023505
• Report Number: 3005994106-2025-00007
• Device Sequence Number: 18423285
• Product Code: LIT
• UDI-Device Identifier: 05391525785943
• UDI-Public: 05391525785943
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K211044
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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 Expiration Date: 04/30/2026
• Device Model Number: SRA-DC18-20080
• Device Lot Number: 22300789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 113 KG