BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFRCT V2.0

    MDR report key: 7029916 · Received November 14, 2017

    Report

    Report Number
    3011276938-2017-00002
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Date of Event
    August 17, 2017
    Report Date
    October 17, 2017
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF HEARTFLOW'S QUALITY MONITORING PROCESS, WE IDENTIFIED A POTENTIAL FALSE NEGATIVE AND INFORMED THE ORDERING PHYSICIAN. (B)(4): THE INVESTIGATION IDENTIFIED A POTENTIAL FALSE NEGATIVE IN THE LAD. THIS WAS DUE TO ANALYST ERROR; WHEN CORRECTED THE REASSESSMENT OF THE ANALYSIS SHOWED A DECREASE IN THE DISTAL FFRCT VALUE FROM 0.92 TO 0.79. 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
    809438 FFRCT V2.0 HEARTFLOW FFRCT PJA HEARTFLOW, INC. FFRCT 2.9 00853341006015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other