FDA Adverse Event
Malfunction
Summary report: N
FFRCT
MDR report key: 8108640
·
Received November 27, 2018
Report
- Report Number
- 3011276938-2018-00009
- Event Type
- Malfunction
- Date Received
- November 27, 2018
- Date of Event
- November 5, 2018
- Report Date
- November 27, 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. HFID # (B)(4): THE INVESTIGATION IDENTIFIED A POTENTIAL FALSE NEGATIVE IN THE LAD. THIS WAS DUE TO ANALYST ERROR; WHEN EDITED THE REASSESSMENT OF THE ANALYSIS SHOWED A POSITIVE FFRCT DISTAL TO THE STENOSIS FROM 0.82 TO 0.76. WHILE HEARTFLOW HAS IDENTIFIED THIS ISSUE, THE PHYSICIAN ACKNOWLEDGES THE COMMUNICATION, AND HAS INDICATED THERE WAS NO HARM TO 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 |
|---|---|---|---|---|---|---|---|
| 947950 | FFRCT | HEARTFLOW FFRCT | PJA | HEARTFLOW, INC. | FFRCT 2.26 | 00853341006015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |