BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTFLOW ANALYSIS

    MDR report key: 23408015 · Received October 28, 2025

    Report

    Report Number
    3021637148-2025-00017
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    October 21, 2025
    Report Date
    October 28, 2025
    Manufacturer
    HEARTFLOW, INC.
    Product Code
    PJA
    UDI-DI
    00853341006701
    PMA / PMN Number
    K250902
    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, A HEARTFLOW ANALYSIS WAS IDENTIFIED TO HAVE BEEN INCORRECTLY RELEASED WITH FFRCT VALUES PROVIDED FOR THE RIGHT CORONARY ARTERY (RCA). THE INVESTIGATION DETERMINED FFRCT VALUES WERE INCORRECTLY PROVIDED IN THE RCA VESSEL DUE TO MISINTERPRETATION OF THE CT DATA BY THE AUTOMATED TECHNOLOGY AND INSPECTION PROCESS. THE PHYSICIAN WAS NOTIFIED OF THE INVESTIGATION RESULTS AND HAS NOT INDICATED A SAFETY EVENT WITH THE PATIENT AT THIS TIME. HEARTFLOW ANALYSIS INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING WARNINGS: 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. THE 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 HEARTFLOW ANALYSIS WAS INCORRECTLY RELEASED WITH FFRCT VALUES PROVIDED FOR THE RIGHT CORONARY ARTERY (RCA) SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1587871 HEARTFLOW ANALYSIS HEARTFLOW ANALYSIS PJA HEARTFLOW, INC. 4.X HFA_4.0.0.2 00853341006701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other