MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-17 for DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM VPR-GW-14 72023-01 manufactured by Cardiovascular Systems, Inc..
| Report Number | 3004742232-2020-00069 |
| MDR Report Key | 9842911 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-17 |
| Date of Report | 2020-04-02 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-03-31 |
| Device Manufacturer Date | 2019-11-04 |
| Date Added to Maude | 2020-03-17 |
| 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 | SARAH HICKS |
| Manufacturer Street | 1225 OLD HIGHWAY 8 NW |
| Manufacturer City | SAINT PAUL, MN |
| Manufacturer Country | US |
| Manufacturer G1 | CARDIOVASCULAR SYSTEMS, INC. |
| Manufacturer Street | 1225 OLD HIGHWAY 8 NW |
| Manufacturer City | SAINT PAUL, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM |
| Generic Name | PERIPHERAL ATHERECTOMY DEVICE |
| Product Code | MCW |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-02-03 |
| Model Number | VPR-GW-14 |
| Catalog Number | 72023-01 |
| Lot Number | 295964 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDIOVASCULAR SYSTEMS, INC. |
| Manufacturer Address | 1225 OLD HIGHWAY 8 NW SAINT PAUL, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-17 |