BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM

    MDR report key: 24369158 · Received February 17, 2026

    Report

    Report Number
    2124215-2026-08891
    Event Type
    Malfunction
    Date Received
    February 17, 2026
    Date of Event
    January 5, 2026
    Report Date
    March 17, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    00191506033309
    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. INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. DEVICE HISTORY RECORD (DHR) REVIEW: SERVICE HISTORY WAS REVIEWED FOR THE AVVIGO PLUS MOB SYSTEM CHINA SN# (B)(6) AND THERE WERE NO SERVICE RECORDS AFTER (B)(6) 2025 WHEN THE CONSOLE WAS LAST SERVICED. AS THERE WERE NO CASES OR COMPLAINTS CREATED FOR THE ALLEGED UNIT PRIOR TO THE CURRENTLY REPORTED EVENTS TO SUGGEST PERFORMANCE ISSUES, IT WAS CONSIDERED FULLY FUNCTIONAL WITH NO ISSUES FROM THAT DATE UNTIL THE REPORTED EVENT DATE OF 30DEC2025. LABELING REVIEW: REVIEW OF THE INSTRUCTIONS FOR USE (IFU) CONFIRMED THERE WAS RELEVANT CONTENT AND SUFFICIENT GUIDANCE WITH RESPECT TO THE CIRCUMSTANCES DESCRIBED WITHIN THIS COMPLAINT. NO UPDATES ARE REQUIRED TO THE IFU AS A RESULT OF THIS EVENT. INVESTIGATION CONCLUSION: BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, THE CAUSE OF THE REPORTED EVENT IS UNKNOWN. DEVICE WAS NOT RETURNED FOR ANALYSIS. THE INVESTIGATION CONCLUSION CODE OF CAUSE NOT ESTABLISHED WAS SELECTED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INCORRECT MEASUREMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE AVVIGO PLUS MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED FOR USE IN A PROCEDURE. DURING THE PROCEDURE, THERE WAS A MISALIGNMENT IN THE LENGTH MEASUREMENT BETWEEN TWO RUNS. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WAS NO PATIENT COMPLICATION AND THE PATIENT FULLY RECOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INCORRECT MEASUREMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE AVVIGO PLUS MULTI-MODALITY GUIDANCE SYSTEM WAS SELECTED FOR USE IN A PROCEDURE. DURING THE PROCEDURE, THERE WAS A MISALIGNMENT IN THE LENGTH MEASUREMENT BETWEEN TWO RUNS. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WAS NO PATIENT COMPLICATION AND THE PATIENT FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    567491 AVVIGO+ MULTI-MODALITY GUIDANCE SYSTEM COMPUTER, DIAGNOSTIC, PROGRAMMABLE, COMPUTER, BLOOD-PRESSURE DQK BOSTON SCIENTIFIC CORPORATION 0105064293 00191506033309

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown