BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM

    MDR report key: 24269335 · Received February 5, 2026

    Report

    Report Number
    2124215-2026-06596
    Event Type
    Malfunction
    Date Received
    February 5, 2026
    Date of Event
    January 12, 2026
    Report Date
    February 5, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B PRO CODE (PRODUCT CODE): DQK, DSK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MEASUREMENT ISSUE OCCURRED. THE AVVIGO PLUS MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED FOR USE IN A PROCEDURE. THE CARDIAC TECHNICAIAN NOTICED THAT THE AUTOMATED LESION ASSESSMENT (ALA) LENGTH DIFFERED FROM THE MANUAL LENGTH THAT HE HAD DRAWN. THE MESUREMENTS WERE NOT USED TO MAKE TREATMENT DECISIONS. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67983 AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE, COMPUTER, BLOOD-PRESSURE DQK BOSTON SCIENTIFIC CORPORATION 0108157662

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown