BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTFLOW ANALYSIS

    MDR report key: 22928373 · Received August 29, 2025

    Report

    Report Number
    3021637148-2025-00013
    Event Type
    Malfunction
    Date Received
    August 29, 2025
    Date of Event
    June 19, 2025
    Report Date
    October 15, 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

    HEARTFLOW RECEIVED A RESPONSE FROM A PHYSICIAN IN CARE OF THE PATIENT WHO STATED "I COULD SEE THE LAD STENT BUT I THOUGHT THE RCA STENT WAS CALCIUM AND THEREFORE INTERPRETABLE WHICH IS WHY I SENT." NO ADDITIONAL FEEDBACK INDICATING A SAFETY EVENT INVOLVING THE PATIENT WAS RECEIVED. ADDITIONAL DATA: H6 - TYPE OF INVESTIGATION, H11 - ADDITIONAL NARRATIVE.

    Additional Manufacturer Narrative · 0

    AS PART OF HEARTFLOW'S INTERNAL REVIEW, WE IDENTIFIED A POTENTIAL INCORRECT CASE ACCEPTANCE. THE INVESTIGATION DETERMINED HEARTFLOW INCORRECTLY ACCEPTED THIS CASE FOR PROCESSING DUE TO MISINTERPRETATION OF THE CT DATA BY THE AUTOMATED TECHNOLOGY AND INSPECTION PROCESS. THE HEARTFLOW ANALYSIS IS NOT VALIDATED TO PROCESS CASES WHEN STENTS ARE PRESENT IN MULTIPLE VESSEL SYSTEMS DUE TO THE UNKNOWN IMPACT ON THE ACCURACY OF THE ANALYSIS. HEARTFLOW NOTIFIED THE PHYSICIAN IN CARE OF THE PATIENT OF THE INVESTIGATION RESULTS. WHILE HEARTFLOW HAS IDENTIFIED THE ISSUE, THE PHYSICIAN HAS NOT PROVIDED ANY FEEDBACK INDICATING A SAFETY EVENT INVOLVING THE PATIENT. 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.

    Description of Event or Problem · 0

    HEARTFLOW IDENTIFIED A COMPUTED TOMOGRAPHY (CT) DATASET WAS POTENTIALLY INCORRECTLY ACCEPTED FOR PROCESSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2163825 HEARTFLOW ANALYSIS HEARTFLOW ANALYSIS PJA HEARTFLOW, INC. FFRCT VERSION 3 HFA_3.40.0.4 00853341006060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other