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

Model Number	SRA-DC18-50100
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the balloon catheter was returned for analysis.Analysis could not confirm the allegation of balloon burst.The balloon was returned in two segments.The balloon separated just proximal to the rapid exchange (rx) port.The balloon segment could not be fully deflated or inflated to confirm a balloon burst due to not being intact.Due to the returned condition, a balloon burst could not be confirmed.
Event or Problem Description
The balloon catheter was used during a percutaneous transluminal angioplasty (pta) procedure.The balloon burst occurred during the first inflation, approximately halfway through the intended inflation period (1-2 minutes).The burst occurred at a pressure of 16atm.Two different balloon sizes were used at other vessel segments at a pressure of 10atm without any issue.The physician chose to use this specific balloon after confirming the pressure range of 8atm (nominal pressure) to 16atm (rated burst pressure).The use of this balloon was the final intended pass for the procedure.After the balloon burst occurred, the physician confirmed the complete balloon was fully in the procedural sheath.The balloon and sheath were removed together and inspected on the back table.The physician then proceeded to site closure.The physician planned to bring the patient back at another time for a below the knee procedure.The target vessel had severe stenosis and tortuosity.There was no significant procedure delay due to the balloon burst.There was no patient harm.

• 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: 22057109
• Report Number: 3005994106-2025-00008
• Device Sequence Number: 8394203
• Product Code: LIT
• UDI-Device Identifier: 05391525786353
• UDI-Public: 05391525786353
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 05/20/2025

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: 06/20/2025
• Device Model Number: SRA-DC18-50100
• Device Lot Number: 22201313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2022
• 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