BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVVIGO?+

    MDR report key: 23694763 · Received December 2, 2025

    Report

    Report Number
    2124215-2025-86244
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 5, 2025
    Report Date
    December 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    00191506033125
    PMA / PMN Number
    K230884
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER ADDRESS: (B)(6). E1: INITIAL REPORTER CITY: (B)(6). D2B PRO CODES CONTINUED: DSK, ITX, IYO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN AVVIGO MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE EQUIPMENT SHOWED A DISTORTED IMAGE WITH ARTIFACTS MAKING ANALYSIS OF THE ARTERY IMPOSSIBLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1899809 AVVIGO?+ COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION H7492493120C0 0108267647 00191506033125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown