MAUDE Adverse Event Report: SURMODICS, INC. SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	SRA-DC18-50040
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: to date, the device had not been returned.If returned, a supplemental mdr will be submitted for analysis results.
Event or Problem Description
The sublime balloon catheter was used in a percutaneous transluminal angioplasty (pta) procedure.The site reported part of the balloon broke off and became stuck in the sheath during removal.The entire balloon was removed without issue.The provided image indicated the balloon broke near the approximate region of the rapid exchange (rx) port.The patient anatomy was reported to be very stenotic and tortuous.The physician did not confirm balloon deflation prior to removal and thought this may have caused the reported issue.The balloon was confirmed to not be fully deflated.The reported issue resulted in a procedure delay of approximately ten minutes.The incident occurred during the end of the procedure.The case was completed without incident.There was no patient harm.
Additional Manufacturer Narrative
H3: the balloon catheter returned for analysis.Analysis confirmed the reported issue.The balloon catheter was returned in two segments.The balloon catheter separated just proximal to the rapid exchange (rx) port.The first segment consisted of the device rx port, inner shaft, section of the outer shaft, and balloon.The second segment consisted of the outer shaft and hypotube, strain relief, and hub.When the segments were measured, there was a length increase by approximately 8.1cm.The balloon, itself, showed signs of bunching.

• Brand Name: SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): SURMODICS, INC.; 7905 golden triangle drive; suite 190; eden prairie MN 55344
• Manufacturer (Section G): SURMODICS, INC.; 7905 golden triangle drive; suite 190; eden prairie MN 55344
• Manufacturer Contact: phil haney ; 7905 golden triangle drive; suite 190; eden prairie, MN 55344 ; 9525007598
• MDR Report Key: 22786638
• Report Number: 3014687026-2025-00004
• Device Sequence Number: 9869810
• Product Code: LIT
• UDI-Device Identifier: 05391525786322
• UDI-Public: 05391525786322
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2025

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-DC18-50040
• Device Lot Number: 22302071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2023
• 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 Sex: Unknown