MAUDE Adverse Event Report: HEARTFLOW, INC. FFRCT; HEARTFLOW FFRCT

Model Number	FFRCT 2.47.0.1
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of heartflow's quality monitoring process, we identified a potential false negative.(b)(4): the investigation identified a potential false negative in the rca region; after the initial analysis was delivered, a second analysis completed as part of ongoing quality review resulted in a decrease in the ffrct value from 0.88 to 0.67 in the rca region.Heartflow was able to confirm with the ordering physician that the reanalysis did not result in consequences or impact to the patient.
Event or Problem Description
Heartflow identified a potential false negative result.

• Brand Name: FFRCT
• Common Device Name: HEARTFLOW FFRCT
• Manufacturer (Section D): HEARTFLOW, INC.; 1400 seaport blvd., bldg. b; redwood city CA 94063 5594
• MDR Report Key: 9633876
• Report Number: 3011276938-2020-00006
• Device Sequence Number: 2800360
• Product Code: PJA
• UDI-Device Identifier: 00853341006015
• UDI-Public: (01)00853341006015(10)FFRCT_2.47.0.1(11)2020-01-01
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K161772
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/27/2020

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 2.47.0.1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other