MAUDE brand profile
APERTA NSE CORONARY DILATATION CATHETER
MAUDE brand safety profile
Key facts
| Brand name | APERTA NSE CORONARY DILATATION 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
- No Clinical Signs, Symptoms or Conditions, Material Rupture, Insufficient Information, Inadequacy of Device Shape and/or Size, Fluid/Blood Leak, Adverse Event Without Identified Device or Use Problem, Material Split, Cut or Torn, Perforation of Vessels 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