BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTFLOW ANALYSIS

    MDR report key: 20043701 · Received August 22, 2024

    Report

    Report Number
    3021637148-2024-00007
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    August 6, 2024
    Report Date
    September 20, 2024
    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

    CORRECTED DATA: H.4 -DEVICE MANUFACTURE DATE WAS INADVERTENTLY LEFT BLANK IN THE INITIAL REPORT. THE CORRECT DATE IS 06-AUG-2024.

    Additional Manufacturer Narrative · 0

    AS PART OF HEARTFLOW'S INTERNAL REVIEW, WE IDENTIFIED A POTENTIAL COMPUTED TOMOGRAPHY (CT) DATASET WAS INCORRECTLY ACCEPTED FOR PROCESSING THE HEARTFLOW ANALYSIS. HFID# BJH-24QLF6-JQBH: THE INVESTIGATION IDENTIFIED THAT THE AVAILABLE CT DATASET DID NOT MEET HEARTFLOW'S IMAGE QUALITY REQUIREMENTS. HEARTFLOW INCORRECTLY ASSESSED IMAGE QUALITY IN THIS DATASET DURING THE ACCEPTANCE OF THIS CASE DUE TO MISINTERPRETATION OF THE CT DATA BY THE AUTOMATED TECHNOLOGY AND INSPECTION PROCESS. THE ACCURACY OF THIS HEARTFLOW ANALYSIS CANNOT BE CONFIRMED DUE TO THE DECREASED CONFIDENCE IN MODELING THROUGH ARTIFACT-AFFECTED REGIONS. THE CUSTOMER WAS NOTIFIED OF THE INVESTIGATION RESULTS AND THEY DID NOT INDICATE A SAFETY EVENT WITH THE PATIENT. THEY WERE ACCEPTING OF THE FINDINGS AND APPRECIATED HEARTFLOW'S COMMITMENT TO QUALITY CONTROL. HEARTFLOW'S ANALYSIS INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING WARNINGS: DUE TO THE VARIABILITY IN THE HEARTFLOW ANALYSIS, THE FFRCT VALUES 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 POTENTIAL COMPUTED TOMOGRAPHY (CT) DATASET WAS INCORRECTLY ACCEPTED FOR PROCESSING AN ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2071035 HEARTFLOW ANALYSIS HEARTFLOW ANALYSIS PJA HEARTFLOW, INC. 3.33.0.4 00853341006060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other