MAUDE manufacturer profile
SPECTRANETICS CORPORATION · DRE
MAUDE profile for Dilator, Vessel, For Percutaneous Catheterization
Key facts
| Manufacturer | SPECTRANETICS CORPORATION |
|---|---|
| Manufacturer group | SPECTRANETICS CORPORATION |
| Product code | DRE |
| Product code name | Dilator, Vessel, For Percutaneous Catheterization |
At a glance
- 100–999 MAUDE reports
- 10–99 Death reports
- 100–999 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Great Vessel Perforation, Perforation of Vessels, Iatrogenic Source, No Clinical Signs, Symptoms or Conditions, Pericardial Effusion, Death, Cardiac Perforation 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