BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFR LINK

    MDR report key: 11274241 · Received February 3, 2021

    Report

    Report Number
    2134265-2021-01199
    Event Type
    Malfunction
    Date Received
    February 3, 2021
    Date of Event
    January 12, 2021
    Report Date
    February 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST SEDATION THE PROCEDURE WAS CANCELLED. A FRACTIONAL FLOW RESERVE PROCEDURE WAS BEING PERFORMED. WHILE ATTEMPTING TO USE THE POLARIS SOFTWARE WITH THIS FFR LINK, THE SOFTWARE WOULD NOT POWERUP PROPERLY. THE PROCEDURE CANCELLED AND THE PATIENT WAS TAKEN OFF OF THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170146 FFR LINK PROGRAMMABLE DIAGNOSTIC COMPUTER, BLOOD PRESSURE COMPUTER DQK BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1