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

Model Number	SRA-DC18-30220
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The sublime balloon catheter was used during a lower extremity intervention via right radial access to treat an occluded anterior tibial artery.The physician reported that multiple manipulations of the device were required to attempt to cross the lesion.The guidewire was believed to have kinked proximal to the lesion, within the superficial femoral artery (sfa).Upon withdrawal of the balloon catheter, resistance was encountered at the location of the wire kink.The physician applied gentle traction, at which point the balloon component separated from the catheter shaft and remained inside the vasculature while still attached to the guidewire.A secondary balloon catheter (jade balloon) was subsequently advanced and used to trap and retrieve the separated balloon segment, enabling successful removal of the device from the patient.The procedure was prolonged due to the retrieval process (over an hour), and pedal access was required to complete treatment of the target vessel.There was no reported patient harm or adverse clinical outcome.
Additional Manufacturer Narrative
H3: the balloon catheter was returned for analysis.Analysis confirmed the reported issue.The balloon catheter was returned in two segments on the guidewire and through a guide sheath.The balloon separated near the rapid exchange (rx) port.The balloon segment was still on the guidewire.The proximal segment of the balloon was off the guidewire and out of the guide sheath.The distal segment of the balloon was trapped on the guidewire by a severe kink.

• Brand Name: SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER
• 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: 23430555
• Report Number: 3005994106-2025-00015
• Device Sequence Number: 8252857
• Product Code: LIT
• UDI-Device Identifier: 05391525786148
• UDI-Public: 05391525786148
• 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): 10/30/2025

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: SRA-DC18-30220
• Device Lot Number: 22401635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2024
• 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