MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2019-05-17 for FFRCT FFRCT 2.36.1.1 manufactured by Heartflow, Inc..
[145637895]
As part of heartflow's quality monitoring process, we identified a potential false negative and will be informing the ordering physician. Hfid # (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 monitoring resulted in a decrease in the ffrct value from 0. 88 to 0. 62 on the distal rca. 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
[145637896]
Heartflow identified a potential false negative result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011276938-2019-00021 |
| MDR Report Key | 8621618 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2019-05-17 |
| Date of Report | 2019-06-11 |
| Date of Event | 2019-04-26 |
| Date Mfgr Received | 2019-05-21 |
| Device Manufacturer Date | 2019-04-26 |
| Date Added to Maude | 2019-05-17 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. PATRICIA ERWIN |
| Manufacturer Street | 1400 SEAPORT BLVD., BLDG. B |
| Manufacturer City | REDWOOD CITY CA 940635594 |
| Manufacturer Country | US |
| Manufacturer Postal | 940635594 |
| Manufacturer Phone | 6502414547 |
| Manufacturer G1 | HEARTFLOW, INC. |
| Manufacturer Street | 1400 SEAPORT BLVD., BLDG. B |
| Manufacturer City | REDWOOD CITY CA 940635594 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 940635594 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FFRCT |
| Generic Name | HEARTFLOW FFRCT |
| Product Code | PJA |
| Date Received | 2019-05-17 |
| Model Number | FFRCT 2.36.1.1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEARTFLOW, INC. |
| Manufacturer Address | 1400 SEAPORT BLVD., BLDG. B REDWOOD CITY CA 940635594 US 940635594 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-05-17 |