BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFRCT V2.0

    MDR report key: 7123827 · Received December 15, 2017

    Report

    Report Number
    3011276938-2017-00004
    Event Type
    Malfunction
    Date Received
    December 15, 2017
    Date of Event
    September 25, 2017
    Report Date
    December 18, 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

    HEARTFLOW WAS ABLE TO CONFIRM WITH THE ORDERING PHYSICIAN THAT THE REASSESSMENT OF THE ANALYSIS WOULD NOT HAVE AFFECTED THEIR DIAGNOSIS AND TREATMENT DECISION, AND DID NOT RESULT IN AN ADVERSE EVENT FOR THIS PATIENT.

    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 LCX SYSTEM. THIS WAS DUE TO ANALYST ERROR; WHEN CORRECTED THE REASSESSMENT OF THE ANALYSIS SHOWED A DECREASE IN THE DISTAL FFRCT VALUE FROM 0.90 TO 0.71. 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
    901961 FFRCT V2.0 HEARTFLOW FFRCT PJA HEARTFLOW, INC. FFRCT 2.8 00853341006015

    Patients

    Seq Age Sex Outcome Treatment
    1 Other