BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTFLOW ANALYSIS

    MDR report key: 22909424 · Received August 27, 2025

    Report

    Report Number
    3021637148-2025-00012
    Event Type
    Malfunction
    Date Received
    August 27, 2025
    Date of Event
    July 28, 2025
    Report Date
    August 27, 2025
    Manufacturer
    HEARTFLOW, INC.
    Product Code
    PJA
    UDI-DI
    00853341006060
    PMA / PMN Number
    K213857
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AS PART OF HEARTFLOW'S INTERNAL REVIEW, WE IDENTIFIED A POTENTIAL FALSE NEGATIVE. THE INVESTIGATION DETERMINED THAT THE PROXIMAL RCA WAS MODELED LARGER THAN WHAT WAS INDICATED IN THE CT DATA DUE TO MISINTERPRETATION BY THE AUTOMATED TECHNOLOGY AND INSPECTION PROCESS. HEARTFLOW HAS NOTIFIED THE PHYSICIAN OF THE INVESTIGATION RESULTS AND HAS NOT INDICATED A SAFETY EVENT WITH THE PATIENT AT THIS TIME. HEARTFLOW'S ANALYSIS INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING WARNING: DUE TO THE VARIABILITY IN THE HEARTFLOW ANALYSIS, THE OUTPUT SHOULD BE REVIEWED AS ONE OF SEVERAL CLINICAL DATA POINTS TO BE USED IN CONJUNCTION WITH THE PATIENT'S ORIGINAL CT IMAGES, CLINICAL HISTORY, SYMPTOMS, AND OTHER DIAGNOSTIC TESTS, AS WELL AS AN APPROPRIATELY TRAINED CLINICIAN'S CLINICAL JUDGMENT, TO EVALUATE THE PATIENT. THE HEARTFLOW ANALYSIS PROCESS IS DEPENDENT ON THE QUALITY OF THE IMAGING DATA PROVIDED. FFRCT VALUES MAY BE AFFECTED BY ASSUMPTIONS NEEDED TO RESOLVE ANATOMY IN AREAS OF UNCERTAINTY, WHETHER PROVIDED BY THE PHYSICIAN OR MADE BY HEARTFLOW CASE ANALYSTS.

    Description of Event or Problem · 0

    HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1405986 HEARTFLOW ANALYSIS HEARTFLOW ANALYSIS PJA HEARTFLOW, INC. FFRCT VERSION 3 HFA_3.41.1.1 00853341006060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other