MAUDE manufacturer profile
PHILIPS VOLCANO · MCW
MAUDE profile for Catheter, Peripheral, Atherectomy
Key facts
| Manufacturer | PHILIPS VOLCANO |
|---|---|
| Manufacturer group | VOLCANO ATHEROMED, INC. |
| Product code | MCW |
| Product code name | Catheter, Peripheral, Atherectomy |
At a glance
- 10–99 MAUDE reports
- 1–9 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, No Clinical Signs, Symptoms or Conditions, Sharp Edges, Vessel Or Plaque, Device Embedded In, Muscle Spasm(s), Vascular Dissection, No Known Impact Or Consequence To Patient, Use of Device 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