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 2019-04-10 for FFRCT FFRCT 2.34.1.1 manufactured by Heartflow, Inc..
[145657087]
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. This was due to analyst error; after the initial analysis was delivered, a second analysis during a quality review resulted in a decrease in the distal ffrct value from 0. 83 to less than 0. 50 on the rca. While heartflow has identified this issue, the physician has not provided feedback, nor indicated a safety event with the patient. No additional follow-up to this mdr is expected.
Patient Sequence No: 1, Text Type: N, H10
[145657088]
Heartflow identified a potential false negative result.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011276938-2019-00015 |
| MDR Report Key | 8500272 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2019-04-10 |
| Date of Report | 2019-05-10 |
| Date of Event | 2019-03-11 |
| Date Mfgr Received | 2019-04-15 |
| Device Manufacturer Date | 2019-03-11 |
| Date Added to Maude | 2019-04-10 |
| 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 | 2019-04-10 |
| Model Number | FFRCT 2.34.1.1 |
| 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 | 2019-04-10 |