MAUDE manufacturer profile
SPECTRANETICS · PNO
MAUDE profile for Catheter, Percutaneous, Cutting/Scoring
Key facts
| Manufacturer | SPECTRANETICS |
|---|---|
| Manufacturer group | SPECTRANETICS |
| Product code | PNO |
| Product code name | Catheter, Percutaneous, Cutting/Scoring |
At a glance
- 100–999 MAUDE reports
- 10–99 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Material Rupture, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Deflation Problem, Entrapment of Device, No Known Impact Or Consequence To Patient, Improper or Incorrect Procedure or Method, Material Separation 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