MAUDE Adverse Event Report: HEARTFLOW, INC. HEARTFLOW ANALYSIS

Model Number	3.33.0.4
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Heartflow identified potential oversized modeling of the left main artery in the heartflow analysis.
Additional Manufacturer Narrative
As part of heartflow's internal review, we identified an oversized modeling of the left main artery in the heartflow analysis.Hfid# (b)(6): the investigation determined that the left main vessel was modeled larger than what is indicated in the ct data due to misinterpretation by heartflow's automated technology and inspection process.The centerline placement was not centered in the lumen in error.Heartflow has notified the customer of the investigation results and the physician has not reported a safety event with the patient.A supplemental medwatch report will be submitted if new information becomes available.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.

• Brand Name: HEARTFLOW ANALYSIS
• Common Device Name: HEARTFLOW ANALYSIS
• Manufacturer (Section D): HEARTFLOW, INC.; 331 e evelyn ave; mountain view CA 94041
• Manufacturer (Section G): HEARTFLOW, INC.; 331 e evelyn ave; moutain view CA 94041
• Manufacturer Contact: avelina alvarado ; 331 e evelyn ave; mountain view, CA 94041 ; 6502411221
• MDR Report Key: 20131357
• Report Number: 3021637148-2024-00008
• Device Sequence Number: 20638295
• Product Code: PJA
• UDI-Device Identifier: 00853341006060
• UDI-Public: (01)00853341006060(10)FFRCT_3.33.0.4(11)2024-08-01
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 09/03/2024

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: 3.33.0.4
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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