MAUDE Adverse Event Report: HEARTFLOW, INC. HEARTFLOW ANALYSIS

Model Number	3.33.0.4
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	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
Heartflow identified a potential computed tomography (ct) dataset was incorrectly accepted for processing an analysis.
Additional Manufacturer Narrative
Corrected data: h.4 -device manufacture date was inadvertently left blank in the initial report.The correct date is 06-aug-2024.

• 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.; mountain view CA 94041
• Manufacturer Contact: avelina alvarado ; 331 e evelyn ave.; mountain view, CA 94041 ; 6502411221
• MDR Report Key: 20043701
• Report Number: 3021637148-2024-00007
• Device Sequence Number: 7955114
• Product Code: PJA
• UDI-Device Identifier: 00853341006060
• UDI-Public: (01)00853341006060(10)FFRCT_3.33.0.4(11)2024-08-06
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

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: 08/06/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/06/2024
• 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