MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · PUM
MAUDE profile for Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | PUM |
| Product code name | Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Clinical Signs, Symptoms or Conditions, Difficult to Remove, Adverse Event Without Identified Device or Use Problem, Positioning Failure, Positioning Problem, Defective Device, Break, Material Integrity Problem 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