MAUDE Adverse Event Report: HEARTFLOW, INC. HEARTFLOW ANALYSIS

Model Number	FFRCT VERSION 3
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of heartflow's internal review, we identified a potential false negative.The investigation determined that the left main and proximal rca were modeled larger than indicated in the computed tomography (ct) data due to misinterpretation by heartflow's 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.The customer site reported that the patient was referred for catheter angiography.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.
Event or Problem Description
Heartflow identified a potential false negative result.

• 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: 22206338
• Report Number: 3021637148-2025-00008
• Device Sequence Number: 7723627
• Product Code: PJA
• UDI-Device Identifier: 00853341006060
• UDI-Public: (01)00853341006060(10)HFA_3.39.0.5(11)2025-05-21
• 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): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/13/2025

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_3.39.0.5
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• 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