BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM

    MDR report key: 24382278 · Received February 18, 2026

    Report

    Report Number
    2124215-2026-09016
    Event Type
    Malfunction
    Date Received
    February 18, 2026
    Date of Event
    January 27, 2026
    Report Date
    May 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION, BUT IT WAS UNABLE TO BE OBTAINED. BECAUSE THE PRODUCT IS UNKNOWN, WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. D2B PRO CODE: DQK, DSK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INCORRECT MEASUREMENT OCCURRED. THE PATIENT WAS BEING TREATED FOR CHRONIC TOTAL OCCLUSION. THE AVVIGO PLUS MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE AUTOMATED LESION ASSESSMENT (ALA) MEASUREMENTS WERE SEVERELY INCORRECT. THE MEASUREMENTS WERE ADJUSTED TO RESOLVE THE ISSUE. THERE WERE NO PATIENT COMPLICATIONS, HOWEVER, THE PROCEDURE WAS PROLONGED. THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548375 AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE, COMPUTER, BLOOD-PRESSURE DQK BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown