BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFR LINK

    MDR report key: 19249965 · Received May 6, 2024

    Report

    Report Number
    2124215-2024-27467
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    April 19, 2024
    Report Date
    March 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    08714729890010
    PMA / PMN Number
    K151613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE CONSOLE WAS TESTED AND FAILED TO TURN ON WHEN THE MAIN POWER WAS TURNED ON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED. AN FFR LINK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS ABLE TO BE ZEROED SUCCESSFULLY BUT WAS UNABLE TO RECORD. AN "UNEXPECTED BEAT" ERROR WAS RECURRING. REBOOTING THE SYSTEM AND REPLACING THE COMET PRESSURE WIRE DID NOT RESOLVE THE ISSUE AND THE CASE WAS ABANDONED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED. AN FFR LINK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS ABLE TO BE ZEROED SUCCESSFULLY BUT WAS UNABLE TO RECORD. AN "UNEXPECTED BEAT" ERROR WAS RECURRING. REBOOTING THE SYSTEM AND REPLACING THE COMET PRESSURE WIRE DID NOT RESOLVE THE ISSUE AND THE CASE WAS ABANDONED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEDATED WITH A LOCAL ANESTHESIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS NOT COMPLETED. AN FFR LINK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE WAS ABLE TO BE ZEROED SUCCESSFULLY BUT WAS UNABLE TO RECORD. AN "UNEXPECTED BEAT" ERROR WAS RECURRING. REBOOTING THE SYSTEM AND REPLACING THE COMET PRESSURE WIRE DID NOT RESOLVE THE ISSUE AND THE CASE WAS ABANDONED. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS SEDATED WITH A LOCAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768005 FFR LINK PROGRAMMABLE DIAGNOSTIC COMPUTER, BLOOD PRESSURE COMPUTER DQK BOSTON SCIENTIFIC CORPORATION 8890 SPM01464 08714729890010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown