ThermoCool SmartTouch Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Cardiac Ablation Catheter (Percutaneous) · First cleared Nov 2004
Total Reports
549
Reports (30d)
22
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Force Sensor Error Before Ablation
qty, medtech, following, patients, group
20
reports
Pericardial Effusion with Cardiac Tamponade
ventricular, required, patient experienced, pericardial, effusion
19
reports
Force Detection Failure During Procedure
evaluation completion, lab received, evaluation evaluation, assessed returned, reportable bwi
10
reports
Identified Hole in Pebax Material
hole pebax, pal identified, pal, lab pal, identified hole
7
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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