BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVVIGO?+

    MDR report key: 25116545 · Received May 7, 2026

    Report

    Report Number
    2124215-2026-24887
    Event Type
    Malfunction
    Date Received
    May 7, 2026
    Date of Event
    April 10, 2026
    Report Date
    May 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    00191506033163
    PMA / PMN Number
    K230884
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRO-CODE: DSK, ITX, IYO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INACCURATE MEASUREMENT OCCURRED. AN AVVIGO PLUS MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED. DURING THE PROCEDURE, THE MINIMAL LUMEN AREA (MLA) MEASUREMENTS WERE INACCURATE. IT WAS ALSO NOTED THAT THE FRACTIONAL FLOW RESERVE (FFR) AND DIASTOLIC HYPEREMIA-FREE RATIO (DFR) VALUES WERE ABLE TO EQUALIZE BUT DISAPPEARED DURING PULLBACK. THE PROCEDURE WAS COMPLETED AND THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118263 AVVIGO?+ COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION H7492493120I0 0102780107 00191506033163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown