MAUDE brand profile
THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY CATHETER
MAUDE brand safety profile
Key facts
| Brand name | THERMOCOOL SMART TOUCH ELECTROPHYSIOLOGY 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
- No Clinical Signs, Symptoms or Conditions, No Consequences Or Impact To Patient, Material Puncture/Hole, Cardiac Tamponade, Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem, Incorrect, Inadequate or Imprecise Result or Readings, Positioning 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