BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONTOUR

    MDR report key: 21976080 · Received May 7, 2025

    Report

    Report Number
    2124215-2025-28645
    Event Type
    Malfunction
    Date Received
    May 7, 2025
    Date of Event
    April 17, 2025
    Report Date
    May 7, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FAD
    UDI-DI
    08714729058502
    PMA / PMN Number
    K974541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A040601 CAPTURES THE REPORTABLE EVENT OF STENT BUCKLED MATERIAL, INSIDE THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE SURGEON TRIED TO INSERT THE STENT AND IT CRUMPLED BEFORE BEING FULLY PLACED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE AND THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423309 CONTOUR STENT, URETERAL FAD BOSTON SCIENTIFIC CORPORATION M0061802220 0035042423 08714729058502

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown