MAUDE Adverse Event Report: HEARTFLOW, INC HEARTFLOW ANALYSIS

Model Number	FFRCT VERSION 3
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of heartflow's internal review, we identified a potential false negative.Hfid # (b)(6): the investigation determined that the left main artery bifurcation and ostial left circuflex (lcx) artery were modeled larger than what is indicated in the computed tomography (ct) data due to misinterpretation by heartflow's automated technology and inspection process.Heartflow will be notifying the customer of the product investigation results.While heartflow has identified this issue, at this moment the physician has not provided any feedback indicating a safety event with the patient.If any new information is received at a later time a supplemental medwatch report will be submitted.Heartflow's 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.
Event or Problem Description
Heartflow identified a potential false negative result.
Additional Manufacturer Narrative
Heartflow provided the investigation results to the customer.The physician reported that the patient did undergo a cardiac catheterization procedure on an unknown date, and it was recommended that they start aggresive therapy.The physician also provided the following partial catheterization findings "40% distal lm, 50% ostial cx, 50% proximal lad confirmed by ifr," but they did not include the actual ifr values or images.Heartflow requested further information from the physician, however, no other information is available at this time.

• Brand Name: HEARTFLOW ANALYSIS
• Common Device Name: HEARTFLOW ANALYSIS
• Manufacturer (Section D): HEARTFLOW, INC; 331 e. evelyn ave; mountain view, ca 94041 CA 94041
• Manufacturer (Section G): HEARTFLOW, INC.; 331 e. evelyn ave.; mountain view CA 94041
• Manufacturer Contact: avelina alvarado ; 331 e. evelyn ave.; mountain view, CA 94041 ; 6502411221
• MDR Report Key: 21130101
• Report Number: 3021637148-2025-00001
• Device Sequence Number: 12469732
• Product Code: PJA
• UDI-Device Identifier: 00853341006060
• UDI-Public: (01)00853341006060(10)FFRCT_3.36.1.2(11)2024-10-30
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

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: FFRCT_3.36.1.2
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2024
• 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