MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · OOB
MAUDE profile for Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | FREUDENBERG MEDICAL |
| Product code | OOB |
| Product code name | Drug-Eluting Percutaneous Transluminal Coronary Angioplasty Catheter |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 10–99 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, Myocardial Infarction, Cardiac Arrest, Failure to Advance, Break 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