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