BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFR LINK

    MDR report key: 24941252 · Received April 21, 2026

    Report

    Report Number
    2124215-2026-21474
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    08714729890010
    PMA / PMN Number
    K151613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER PHONE: (B)(6)

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A FFR LINK AND COMET PRESSURE GUIDEWIRES WERE SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE DISTAL BLOOD PRESSURE PD (BLUE) IS OFFSET UPWARD WITH A LARGE GAP, PREVENTING DFR AND FRACTIONAL FLOW RESERVE (FFR) COMPUTATION AND HAD STRANGE MEASUREMENT RESULTS. PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT AND AFTER USING FIFTH COMET PRESSURE GUIDEWIRE, LAST ATTEMPT, PATIENT WAS SENT TO ANOTHER HOSPITAL. PATIENT IS STABLE AND IN GOOD CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422127 FFR LINK PROGRAMMABLE DIAGNOSTIC COMPUTER, BLOOD PRESSURE COMPUTER DQK BOSTON SCIENTIFIC CORPORATION H7495551000 SPM13020 08714729890010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown