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

Model Number	FFRCT 2.60.1.1
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/21/2020
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 0.92 to 0.51 on the distal rca.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.
Additional Manufacturer Narrative
Corrected date in g3 from 12/21/2020 to 1/6/2021.

• 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: 11181805
• Report Number: 3011276938-2021-00001
• Device Sequence Number: 2870488
• Product Code: PJA
• UDI-Device Identifier: 00853341006039
• UDI-Public: (01)00853341006039(10)FFRCT_2.60.1.1(11)2020-12-21
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K203329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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 2.60.1.1
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 12/21/2020
• Supplement Date Received by Manufacturer: 01/06/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 03/09/2021
• 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