MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · ONU
MAUDE profile for Drug-Eluting Peripheral Transluminal Angioplasty Catheter
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | HEMOTEQ AG |
| Product code | ONU |
| Product code name | Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
At a glance
- 1,000+ MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Material Rupture, Restenosis, Vascular Dissection, Obstruction/Occlusion, Arteriosclerosis/ Atherosclerosis, Ischemia 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