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