FDA Adverse Event
Malfunction
Summary report: N
FFRCT
MDR report key: 8175617
·
Received December 18, 2018
Report
- Report Number
- 3011276938-2018-00010
- Event Type
- Malfunction
- Date Received
- December 18, 2018
- Date of Event
- November 14, 2018
- Report Date
- December 18, 2018
- 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 AND INFORMED THE ORDERING PHYSICIAN. (B)(4): THE INVESTIGATION IDENTIFIED A POTENTIAL FALSE NEGATIVE IN THE LCX. THIS WAS DUE TO ANALYST ERROR; WHEN EDITED THE REASSESSMENT OF THE ANALYSIS SHOWED A DECREASE IN THE FFRCT VALUE FROM 0.94 TO 0.66 AT THE DISTAL LCX. WHILE HEARTFLOW HAS IDENTIFIED THIS ISSUE, THE PHYSICIAN HAS NOT PROVIDED FEEDBACK, NOR HAS INDICATED A SAFETY EVENT WITH THE PATIENT. NO ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED.
Description of Event or Problem · 1
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1015751 | FFRCT | HEARTFLOW FFRCT | PJA | HEARTFLOW, INC. | FFRCT 2.27 | 00853341006015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |