BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVVIGO?+

    MDR report key: 23611477 · Received November 20, 2025

    Report

    Report Number
    2124215-2025-85180
    Event Type
    Malfunction
    Date Received
    November 20, 2025
    Date of Event
    October 1, 2025
    Report Date
    November 20, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    00191506033163
    PMA / PMN Number
    K230884
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT. FIRST DATE OF THE MONTH USED AS ACTUAL DATE IS UNKNOWN. D2B PRO CODE: DSK, ITX, IYO

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TABLE SIDE CONTROLLER WAS SPARKING. OUTSIDE OF A PROCEDURE, IT WAS NOTED THAT THE AVVIGO PLUS SYSTEM TABLE SIDE CONTROLLER HAD VISIBLE SPARKS COMING OFF OF IT. THE HOSPITAL STAFF TURNED OFF POWER TO THE SYSTEM, AND THERE WAS NO INJURY CAUSED BY THIS MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308323 AVVIGO?+ COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION H7492493120I0 0104655433 00191506033163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown