MAUDE Adverse Event Report: HEARTFLOW, INC. HEARTFLOW ANALYSIS

Model Number	FFRCT VERSION 3
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Heartflow identified a computed tomography (ct) dataset was potentially incorrectly accepted for processing.
Additional Manufacturer Narrative
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.

• Brand Name: HEARTFLOW ANALYSIS
• Common Device Name: HEARTFLOW ANALYSIS
• Manufacturer (Section D): HEARTFLOW, INC.; 331 e evelyn ave; mountain view CA 94041 1530
• Manufacturer (Section G): HEARTFLOW, INC.; 331 e evelyn ave; mountain view CA 94041 1530
• Manufacturer Contact: avelina alvarado ; 331 e evelyn ave; mountain view, CA 94041-1530 ; 6502411221
• MDR Report Key: 22928373
• Report Number: 3021637148-2025-00013
• Device Sequence Number: 18416152
• Product Code: PJA
• UDI-Device Identifier: 00853341006060
• UDI-Public: (01)00853341006060(10)HFA_3.40.0.4(11)2025-06-19
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K213857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FFRCT VERSION 3
• Device Lot Number: HFA_3.40.0.4
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown