BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIA? SOFT

    MDR report key: 23206375 · Received October 2, 2025

    Report

    Report Number
    2124215-2025-68593
    Event Type
    Malfunction
    Date Received
    October 2, 2025
    Date of Event
    September 9, 2025
    Report Date
    October 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    UDI-DI
    08714729959939
    PMA / PMN Number
    K191609
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT KINKED INSIDE THE PATIENT. BLOCKS B5, E1, E3, AND H6, HAVE BEEN UPDATED BASED ON THE ADDITIONAL INFORMATION RECEIVED ON OCTOBER 03, 2025. ADDITIONAL INFORMATION WAS RECEIVED FROM THE COMPLAINANT ON OCTOBER 03, 2025, CLARIFIED THAT THE REPORTED ISSUE WAS THE COIL WAS ALSO DETACHED, HOWEVER, THE EVENT OCCURRED OUTSIDE THE PATIENT. ALTHOUGH THIS CAN RESULT IN A CLINICALLY INSIGNIFICANT DELAY OF THE PROCEDURE, THIS EVENT IS UNLIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO RECUR. BASED ON THE REVIEW OF THE INFORMATION, THIS EVENT NO LONGER MEETS REPORTING CRITERIA.

    Additional Manufacturer Narrative · 0

    . DEVICE CODE A0406 CAPTURES THE REPORTABLE EVENT OF STENT KINKED INSIDE THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY, URETER AND BLADDER. DURING INSERTION, IT WAS NOTICED THAT THE STENT KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE DAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION RECEIVED ON OCTOBER 03, 2025, CLARIFIED THAT THE EVENT OCCURRED OUTSIDE THE PATIENT AND THE COIL WAS ALSO DETACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TRIA URETERAL STENT WAS USED IN A URETEROSCOPY PROCEDURE IN THE KIDNEY, URETER AND BLADDER. DURING INSERTION, IT WAS NOTICED THAT THE STENT KINKED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE DAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2434498 TRIA? SOFT STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION M0061903320 0035745977 08714729959939

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown