BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFRCT

    MDR report key: 8004784 · Received October 25, 2018

    Report

    Report Number
    3011276938-2018-00006
    Event Type
    Malfunction
    Date Received
    October 25, 2018
    Date of Event
    September 20, 2018
    Report Date
    October 25, 2018
    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

    DURING AN INTERNAL REVIEW PROCESS, HEARTFLOW IDENTIFIED A DIFFERENT RESULT THAN THAT WHICH WAS ORIGINALLY PROVIDED AND INFORMED THE ORDERING PHYSICIAN ON (B)(4) 2018. THE INVESTIGATION FOR HEARTFLOW ID CASE# (B)(4) IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THIS WAS DUE TO ANALYST ERROR; WHEN CORRECTED, THE REASSESSMENT OF THE ANALYSIS SHOWED A DECREASE IN THE FFRCT VALUE FROM 0.83 TO 0.67 AT THE DLAD. ON (B)(6) 2018, THE PHYSICIAN REPORTED THE HEARTFLOW ANALYSIS WAS UPDATED, INFORMED THE INTERVENTIONAL CARDIOLOGISTS AND FURTHER REPORTED NO CONCERNS WITH THE PATIENT. NO ADDITIONAL FOLLOW-UP 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
    847796 FFRCT HEARTFLOW FFRCT PJA HEARTFLOW, INC. FFRCT 2.23 00853341006015

    Patients

    Seq Age Sex Outcome Treatment
    1