BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFRCT

    MDR report key: 8313234 · Received February 6, 2019

    Report

    Report Number
    3011276938-2019-00007
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    December 18, 2018
    Report Date
    February 6, 2019
    Manufacturer
    HEARTFLOW, INC.
    Product Code
    PJA
    UDI-DI
    00853341006015
    PMA / PMN Number
    K161772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF HEARTFLOW'S QUALITY MONITORING PROCESS, WE IDENTIFIED A POTENTIAL FALSE NEGATIVE AND INFORMED THE ORDERING PHYSICIAN. HFID #LHN-181218-QXRX: THE INVESTIGATION IDENTIFIED A POTENTIAL FALSE NEGATIVE IN THE RCA AND LCX. THIS WAS DUE TO ANALYST ERROR; AFTER THE INITIAL ANALYSIS WAS DELIVERED, A SECOND ANALYSIS DURING A QUALITY REVIEW RESULTED IN A DECREASE IN THE DISTAL FFRCT VALUE FROM 0.83 TO 0.72 AT THE RCA AND 0.85 TO 0.71 ON THE LCX. WHILE HEARTFLOW HAS IDENTIFIED THIS ISSUE, THE PHYSICIAN HAS NOT PROVIDED FEEDBACK, NOR INDICATED A SAFETY EVENT WITH THE PATIENT. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED.

    Description of Event or Problem · 1

    HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105032 FFRCT HEARTFLOW FFRCT PJA HEARTFLOW, INC. FFRCT 2.29 00853341006015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other