MAUDE manufacturer profile
THE SPECTRANETICS CORPORATION · MJN
MAUDE profile for Catheter, Intravascular Occluding, Temporary
Key facts
| Manufacturer | THE SPECTRANETICS CORPORATION |
|---|---|
| Manufacturer group | SPECTRANETICS |
| Product code | MJN |
| Product code name | Catheter, Intravascular Occluding, Temporary |
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Failure to Advance, Adverse Event Without Identified Device or Use Problem, Deflation Problem, No Clinical Signs, Symptoms or Conditions, Thrombus, Device Operates Differently Than Expected 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