BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVVIGO?+

    MDR report key: 24570726 · Received March 11, 2026

    Report

    Report Number
    2124215-2026-13603
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    February 3, 2026
    Report Date
    March 11, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    00191506033125
    PMA / PMN Number
    K230884
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B, PRO CODE (PRODUCT CODE), DSK, ITX, IYO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. DURING THE PROCEDURE, AN AVVIGO MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED FOR USE, THE IMAGE SHOWED UP WAS AFFECTED BY A SNOWFLAKE-LIKE ARTIFACT. THE PROCEDURE WAS CANCELLED DUE TO THE ISSUE PRIOR TO TREATMENT BEING COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469218 AVVIGO?+ COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION H7492493120C0 0108284591 00191506033125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown