FFRCT FFRCT 2.34.3.1

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2019-04-26 for FFRCT FFRCT 2.34.3.1 manufactured by Heartflow, Inc..

Event Text Entries

[144149254] As part of heartflow's quality monitoring process, we identified a potential false negative and will be informing the ordering physician. (b)(6): the investigation identified a potential false negative in the lad region; after the initial analysis was delivered, a second analysis during a quality review resulted in a decrease in the distal ffrct value from 0. 88 to less than 0. 57 on the lad. While heartflow has identified this issue, the physician has not provided feedback, nor indicated a safety event with the patient.
Patient Sequence No: 1, Text Type: N, H10


[144149255] Heartflow identified a potential false negative result.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3011276938-2019-00017
MDR Report Key8554566
Report SourceOTHER
Date Received2019-04-26
Date of Report2019-07-03
Date of Event2019-04-05
Date Mfgr Received2019-06-10
Device Manufacturer Date2019-04-05
Date Added to Maude2019-04-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. PATRICIA ERWIN
Manufacturer Street1400 SEAPORT BLVD., BLDG. B
Manufacturer CityREDWOOD CITY CA 940635594
Manufacturer CountryUS
Manufacturer Postal940635594
Manufacturer Phone6502414547
Manufacturer G1HEARTFLOW, INC.
Manufacturer Street1400 SEAPORT BLVD., BLDG. B
Manufacturer CityREDWOOD CITY CA 940635594
Manufacturer CountryUS
Manufacturer Postal Code940635594
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFFRCT
Generic NameHEARTFLOW FFRCT
Product CodePJA
Date Received2019-04-26
Model NumberFFRCT 2.34.3.1
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHEARTFLOW, INC.
Manufacturer Address1400 SEAPORT BLVD. BLDG., B REDWOOD CITY CA 940635594 US 940635594


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2019-04-26

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