BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFR LINK

    MDR report key: 24671245 · Received March 23, 2026

    Report

    Report Number
    2124215-2026-15960
    Event Type
    Malfunction
    Date Received
    March 23, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 23, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    08714729890010
    PMA / PMN Number
    K151613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A FFR LINK AND PHILIPS XPER LNG CABLE WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE UNIT DOES NOT DISPLAY A PRESSURE. THE PROCEDURE WAS ABORTED. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56832 FFR LINK PROGRAMMABLE DIAGNOSTIC COMPUTER, BLOOD PRESSURE COMPUTER DQK BOSTON SCIENTIFIC CORPORATION H7495551000 SPM05136 08714729890010

    Patients

    Seq Age Sex Outcome Treatment
    1