MAUDE manufacturer profile
SPECTRANETICS CORPORATION · DRB
MAUDE profile for Stylet, Catheter
Key facts
| Manufacturer | SPECTRANETICS CORPORATION |
|---|---|
| Manufacturer group | SPECTRANETICS CORPORATION |
| Product code | DRB |
| Product code name | Stylet, Catheter |
At a glance
- 1,000+ 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, Device Embedded In Tissue or Plaque, Cardiac Perforation, Iatrogenic Source, Pericardial Effusion, Break, Low Blood Pressure/ Hypotension, Mechanical 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