MAUDE manufacturer profile
THE SPECTRANETICS CORPORATION · ONU
MAUDE profile for Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Key facts
| Manufacturer | THE SPECTRANETICS CORPORATION |
|---|---|
| Manufacturer group | SPECTRANETICS |
| Product code | ONU |
| Product code name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Reocclusion, Death, Occlusion, Stenosis, Material Rupture, Cancer, Occlusion Within Device Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE manufacturer and product code profiles
Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1