MAUDE MDR 9847053
- MDR report key
- 9847053
- Report number
- 3004742232-2020-00086
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-26
- Date received
- 2020-03-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Devices#
Seq, Brand, Generic table| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|
| 1 | DIAMONDBACK PERIPHERAL ORBITAL ATHERECTOMY SYSTEM (VIPERWIRE) | PERIPHERAL ATHERECTOMY DEVICE (GUIDE WIRE) | CARDIOVASCULAR SYSTEMS, INC. | MCW | VPR-GW-FT14 | 7-10041-03 | 297058 | | | | R
| N |
Patients#
Sequence, Received, Treatment table| Sequence | Received | Treatment | Outcome |
|---|
| 1 | 2020-03-18 | 0 | 1. O
|
Event Narratives#
No narrative records found.