MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-03-28 for FFRCT FFRCT 2.30 manufactured by Heartflow, Inc..
[140278795]
Hfid # (b)(4): the investigation identified a potential false negative in the lad. This was due to analyst error; after the initial analysis was delivered, a second analysis during the investigation resulted in a decrease in the distal ffrct value from 0. 84 to 0. 67 on the lad. Heartflow will be informing the ordering physician of the investigation results.
Patient Sequence No: 1, Text Type: N, H10
[140278796]
On (b)(6) 2019: an ffrct analysis was ordered and results indicated the distal ffrct value of 0. 84 on the lad. On (b)(6) 2019: a case review was held with the physician and heartflow personnel. During the case review the physician leading the review provided information that a patient who had received an ffrct analysis on (b)(6) 2019 and results interpreted as "negative" was admitted to the emergency room for chest pain at a neighboring hospital. The physician indicated that they read the initial computed tomography (ct) scan as 50-70% stenosis in the proximal lad and 50-70% stenosis in the mid-lad. The patient received another ct scan at the emergency room. The patient was discharged from the emergency room, and referred for cardiac catheterization. The patient is under the care of the neighboring hospital physicians. On (b)(6) 2019: follow-up with the physician was performed to discuss this case to confirm the details provided during the case review. The physician noted they will request a copy of the ct scan and cardiac catheterization from the neighboring hospital. On (b)(6) 2019: follow-up with the physician was performed to obtain additional information including the sequence of events and the physician confirmed it is being worked on.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3011276938-2019-00013 |
| MDR Report Key | 8461676 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-28 |
| Date of Event | 2019-01-18 |
| Date Mfgr Received | 2019-03-12 |
| Device Manufacturer Date | 2019-01-18 |
| Date Added to Maude | 2019-03-28 |
| 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 | 2019-03-28 |
| Model Number | FFRCT 2.30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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. Hospitalization | 2019-03-28 |