BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS? ULTRA

    MDR report key: 23376326 · Received October 24, 2025

    Report

    Report Number
    2124215-2025-75907
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    September 23, 2025
    Report Date
    October 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    PMA / PMN Number
    K010002
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT KINKED.

    Description of Event or Problem · 0

    IT WAS NOTED THAT DURING THE LASER NEPHROLITHOTOMY AND DOUBLE J CATHETER REMOVAL PROCEDURE, THE PHYSICIAN ENCOUNTERED DIFFICULTY WHEN INSERTING THE DOUBLE J CATHETER, AS IT DID NOT PASS SMOOTHLY THROUGH THE GUIDE. THE PHYSICIAN APPLIED FORCE TO ADVANCE IT, BUT ONCE INSIDE THE CAVITY, THE CATHETER DID NOT FIT CORRECTLY AND WAS BENT. CONSEQUENTLY, THE UROLOGIST OPTED TO REMOVE IT AND REPLACE IT WITH ANOTHER DOUBLE J CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A DIFFERENT DEVICE OF THE SAME TYPE, AND THERE WERE NO KNOWN PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232689 POLARIS? ULTRA STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION M0061921320 0035639001

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male