BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER

    MDR report key: 22786638 · Received August 12, 2025

    Report

    Report Number
    3014687026-2025-00004
    Event Type
    Malfunction
    Date Received
    August 12, 2025
    Date of Event
    July 15, 2025
    Report Date
    October 23, 2025
    Manufacturer
    SURMODICS, INC.
    Product Code
    LIT
    UDI-DI
    05391525786322
    PMA / PMN Number
    K211044
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: TO DATE, THE DEVICE HAD NOT BEEN RETURNED. IF RETURNED, A SUPPLEMENTAL MDR WILL BE SUBMITTED FOR ANALYSIS RESULTS.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2462143 SUBLIME¿ RADIAL ACCESS 018 RX PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT SURMODICS, INC. SRA-DC18-50040 22302071 05391525786322

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown