FDA Adverse Event
Malfunction
Summary report: N
FFRCT
MDR report key: 9613397
·
Received January 21, 2020
Report
- Report Number
- 3011276938-2020-00003
- Event Type
- Malfunction
- Date Received
- January 21, 2020
- Date of Event
- December 26, 2019
- Report Date
- January 21, 2020
- Manufacturer
- HEARTFLOW, INC.
- Product Code
- PJA
- UDI-DI
- 00853341006015
- PMA / PMN Number
- K161772
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 501
Narratives
Additional Manufacturer Narrative · 1
AS PART OF HEARTFLOW'S QUALITY MONITORING PROCESS, WE IDENTIFIED A POTENTIAL FALSE NEGATIVE. HFID # TVH-191226-YNWW: THE INVESTIGATION IDENTIFIED A POTENTIAL FALSE NEGATIVE IN THE LAD 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 0.85 TO 0.59 IN THE LAD REGION. WHILE HEARTFLOW HAS IDENTIFIED THIS ISSUE, THE PHYSICIAN HAS NOT PROVIDED FEEDBACK, NOR INDICATED A SAFETY EVENT WITH THE PATIENT.
Description of Event or Problem · 1
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 73338 | FFRCT | HEARTFLOW FFRCT | PJA | HEARTFLOW, INC. | FFRCT 2.47.0.1 | 00853341006015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |