MAUDE manufacturer profile
THE SPECTRANETICS CORPORATION · NWX
MAUDE profile for Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring
Key facts
| Manufacturer | THE SPECTRANETICS CORPORATION |
|---|---|
| Manufacturer group | SPECTRANETICS |
| Product code | NWX |
| Product code name | Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring |
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
- Material Rupture, No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Detachment of Device or Device Component, Break, Atherosclerosis, Deflation Problem, Entrapment of Device 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