MAUDE manufacturer profile
BOSTON SCIENTIFIC - MINN · GBA
MAUDE profile for Catheter, Balloon Type
Key facts
| Manufacturer | BOSTON SCIENTIFIC - MINN |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC - MINN |
| Product code | GBA |
| Product code name | Catheter, Balloon Type |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Fluid/Blood Leak, Vascular Dissection, Leak/Splash, Stroke/CVA, Material Rupture 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