BEUDAMED
    FDA Adverse Event Other Summary report: N

    NITINOL STONE RETRIEVAL DEVICE

    MDR report key: 22339265 · Received June 25, 2025

    Report

    Report Number
    MW5171971
    Event Type
    Other
    Date Received
    June 25, 2025
    Date of Event
    June 13, 2025
    Report Date
    June 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FFL
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    7MM STONE LOCATED IN DISTAL URETER OF PATIENT WITH ELEVATED BLADDER NECK AND TIGHT DISTAL URETER. LITHOTRIPSY VIA LASER FIBER DONE AND BASKET USED TO REMOVE FRAGMENTS. THE BASKED BROKE DURING THE PROCEDURE. DISTAL BASKET REMOVED AND CYSTOSCOPE ADVANCES PER URETHRA TO REMOVE BASKET FRAGMENTS WITHOUT ISSUE. PROCEDURE STAGED AND STENT PLACED. NO INJURY NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1003570 NITINOL STONE RETRIEVAL DEVICE DISLODGER, STONE, BASKET, URETERAL, METAL FFL BOSTON SCIENTIFIC CORPORATION M006-390501-0 36203879

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male