MAUDE brand profile
VISIONS PV014P RX DIGITAL IVUS CATHETER
MAUDE brand safety profile
Key facts
| Brand name | VISIONS PV014P RX DIGITAL IVUS CATHETER |
|---|
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 1–9 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Material Separation, No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Material Split, Cut or Torn, Device Embedded In Tissue or Plaque, Material Protrusion/Extrusion, Sharp Edges, Adverse Event Without Identified Device or Use Problem Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1