BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM

    MDR report key: 24334713 · Received February 13, 2026

    Report

    Report Number
    2124215-2026-08217
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    January 22, 2026
    Report Date
    March 19, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE: DSK. D4 EXPIRATION DATE: 12/31/9999. E1: INITIAL REPORTER FACILITY NAME: (B)(6) UNIVERSITY.

    Additional Manufacturer Narrative · 0

    D2B: PRO CODE: DSK D4 EXPIRATION DATE: 12/31/9999 E1: INITIAL REPORTER FACILITY NAME: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN AVVIGO MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED FOR USE. PRIOR TO THE PROCEDURE, THE DEVICE ALERTED ERROR CODE 1101 AND THE PROCEDURE WAS NOT COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN AVVIGO MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED FOR USE. PRIOR TO THE PROCEDURE, THE DEVICE ALERTED ERROR CODE 1101 AND THE PROCEDURE WAS NOT COMPLETED. IT WAS LATER REPORTED THAT THE PROCEDURE WAS NOT CANCELLED, AND THAT THE PROCEDURE WAS COMPLETED WITHOUT ANY PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237444 AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE, COMPUTER, BLOOD-PRESSURE DQK BOSTON SCIENTIFIC CORPORATION 0000400163

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown