BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVVIGO?+

    MDR report key: 25116542 · Received May 7, 2026

    Report

    Report Number
    2124215-2026-23407
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B PRO CODE: DSK, ITX, IYO. H3 DEVICE EVAL BY MANUFACTURER: PRODUCT INVESTIGATION IS NOT READY OR HAS NOT BEEN COMPLETED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MLA MEASUREMENT WAS INACCURATE. AVVIGO PLUS MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED. DURING THE PROCEDURE, MLA MEASUREMENTS WERE INACCURATE AND THE FFR/DFR WERE ABLE TO EQUALIZE BUT THE VALUES DISAPPEARED DURING PULLBACK. NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    118113 AVVIGO?+ COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION H7492493120I0 0102783371 00191506033163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown