MAUDE Adverse Event Report: HEARTFLOW, INC. HEARTFLOW ANALYSIS

Model Number	3.31.1.1
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	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of heartflow's internal review, we identified a heartflow analysis was incorrectly released with ffrct values provided for the right coronary artery (rca) system.Phs-24z8n7-xjrb: the investigation identified heartflow incorrectly provided an analysis for the rca system due to misinterpretation of the ct data by heartflow's automated technology and inspection process.Ffrct values should not have been provided in the rca system because the proximal to mid-rca lumen boundaries are unclear due to motion in the presence of calcified and potential non-calcified plaque.The customer was notified of the investigation results.The physician did not communicate any comments or concerns, nor did they report 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 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 heartflow analysis was incorrectly released with ffrct values provided for the right coronary artery (rca) system.

• 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: 19672341
• Report Number: 3021637148-2024-00006
• Device Sequence Number: 6587452
• Product Code: PJA
• UDI-Device Identifier: 00853341006060
• UDI-Public: (01)00853341006060(10)FFRCT_3.31.1.1(11)2024-06-20
• 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): 07/03/2024

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: 3.31.1.1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2024
• 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