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

Model Number	FFRCT 2.46.0.1
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/21/2019
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 lcx 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 0.77 to less than 0.50 in the lcx region.Since the ffrct value of 0.77 was calculated in the large lcx vessel, the reported change to an ffrct value of less than 0.50 is potential clinically relevant.While heartflow has identified this issue, the physician has not provided feedback, nor indicated a safety event with 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: 9492707
• Report Number: 3011276938-2019-00061
• Device Sequence Number: 16664095
• Product Code: PJA
• UDI-Device Identifier: 00853341006015
• UDI-Public: (01)00853341006015(10)FFRCT_2.46.0.1(11)2019-11-21
• 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): 12/18/2019

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 2.46.0.1
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2019
• Initial Report FDA Received Date: 12/19/2019
• 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