MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · DRA
MAUDE profile for Catheter, Steerable
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | CENTERPOINT SYSTEMS |
| Product code | DRA |
| Product code name | Catheter, Steerable |
At a glance
- 1,000+ MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 1,000+ Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Air/Gas in Device, Leak/Splash, Adverse Event Without Identified Device or Use Problem, Device Contamination with Body Fluid, Material Integrity Problem, Low Blood Pressure/ Hypotension, Difficult to Advance 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