MAUDE brand profile
THERMOCOOL SMARTTOUCH SF UNIDIRECTIONAL NAV CATHETER
MAUDE brand safety profile
Key facts
| Brand name | THERMOCOOL SMARTTOUCH SF UNIDIRECTIONAL NAV CATHETER |
|---|
At a glance
- 100–999 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 10–99 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Cardiac Tamponade, Insufficient Information, Adverse Event Without Identified Device or Use Problem, Low Blood Pressure/ Hypotension, Device Operates Differently Than Expected, No Known Impact Or Consequence To Patient, No Consequences Or Impact To Patient, Device Displays Incorrect Message 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