MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · OAE
MAUDE profile for Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC CORPORATION |
| Product code | OAE |
| Product code name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
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
- No Clinical Signs, Symptoms or Conditions, Adverse Event Without Identified Device or Use Problem, Improper Flow or Infusion, Material Integrity Problem, Temperature Problem, Pericardial Effusion, Cardiac Tamponade, Device Displays Incorrect Message 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