BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VASSALLO GT FLOPPY

    MDR report key: 24899990 · Received April 16, 2026

    Report

    Report Number
    3023139607-2026-00001
    Event Type
    Malfunction
    Date Received
    April 16, 2026
    Date of Event
    March 18, 2026
    Report Date
    April 10, 2026
    Manufacturer
    FILMECC CO., LTD.
    Product Code
    DQX
    UDI-DI
    04582105830028
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CUSTOMER REPORTS THEY HAD 2 WIRES WITH GREAT DIFFICULTY ADVANCING AND REMOVING FROM A CATHETER AND "SHEERING OFF". THE FIRST CASE WAS LAST WEEK FOR A GENICULAR EMBOLIZATION CASE USING THE WIRE IN A TERUMO PROGREAT MICROCATHETER AND THE SECOND CASE WAS TODAY FOR AN ANGIOGRAPHY USING AN 014 BOSTON SCIENTIFIC RUBICON CATHETER. THE PHYSICIAN IS STOPPING USE AND WILL BE HANDING WHAT IS LEFT OF 1 BOX AND 2 FULL BOXES TO RETURN FOR A SWAP OF PRODUCT WITH A DIFFERENT LOT NUMBER. I WILL SHIP OUT THE PRODUCT THIS WEEK. NOTHING WAS LEFT BEHIND IN THE BODY. THE FIRST CASE WAS GAE (GENICULAR ARTERY EMBOLIZATION) THAT TREATS KNEE PAIN. THE VESSELS ARE NONSTENOTIC. THE WIRE WAS CAUGHT UP IN A TERUMO MICRO CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285024 VASSALLO GT FLOPPY PERIPHERAL GUIDE WIRE DQX FILMECC CO., LTD. 250924R011 04582105830028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown