BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVVIGO?+

    MDR report key: 22203758 · Received June 13, 2025

    Report

    Report Number
    2124215-2025-38394
    Event Type
    Malfunction
    Date Received
    June 13, 2025
    Date of Event
    May 23, 2025
    Report Date
    November 14, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    00191506033125
    PMA / PMN Number
    K230884
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B ADDITIONAL PRO CODES: DSK, ITX, IYO.

    Additional Manufacturer Narrative · 0

    D2B ADDITIONAL PRO CODES: DSK, ITX, IYO. THE RETURNED PRODUCT CONSISTED OF THE MOTOR DRIVE UNIT (MDU). A VISUAL INSPECTION REVEALED CORROSION ON THE ROTATING DIRECT CONNECTION SOCKET PINS. TESTING THE MDU WITH A CATHETER DID NOT CAUSE ANY ISSUES. THE DEVICE MALFUNCTION COULD NOT BE DUPLICATED DURING FUNCTIONAL TESTING. THIS INVESTIGATION IS ASSIGNED A CONCLUSION CODE OF NO PROBLEM DETECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM MISIDENTIFIED THE IMAGING CATHETER. AN AVVIGO PLUS IMAGING SYSTEM WAS SELECTED FOR EXAMINATION OF THE TARGET LESION. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE MOTOR DRIVE UNIT WAS MISREADING CATHETERS, AND THE CATHETERS WERE NOT ABLE TO COMPLETELY LOCK IN. DESPITE THE ISSUE, THE AVVIGO PLUS SYSTEM WAS STILL USED TO MAKE TREATMENT DECISIONS. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY, AND THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYSTEM MISIDENTIFIED THE IMAGING CATHETER. AN AVVIGO PLUS IMAGING SYSTEM WAS SELECTED FOR EXAMINATION OF THE TARGET LESION. PRIOR TO THE PROCEDURE, IT WAS NOTED THAT THE MOTOR DRIVE UNIT WAS MISREADING CATHETERS, AND THE CATHETERS WERE NOT ABLE TO COMPLETELY LOCK IN. DESPITE THE ISSUE, THE AVVIGO PLUS SYSTEM WAS STILL USED TO MAKE TREATMENT DECISIONS. THE PROCEDURE WAS ABLE TO BE COMPLETED SUCCESSFULLY, AND THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353120 AVVIGO?+ COMPUTER, DIAGNOSTIC, PROGRAMMABLE DQK BOSTON SCIENTIFIC CORPORATION H7492493120C0 0107864411 00191506033125

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown