ThermoCool SmartTouch Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Cardiac Ablation Catheter (Percutaneous) · First cleared Nov 2004
Total Reports
590
Reports (30d)
1
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Irrigation Failure During Atrial Ablation
pebax, tubing, patient underwent, patient experienced, procedure thermocool
24
reports
Literature Batch: Atrial Fibrillation Ablation Outcomes
devices, qty, possibly, possibly associated, literature
21
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Comparison of the lesion formation and safety in ex vivo porcine heart study: Using ThermoCool SmartTouch and ThermoCool SmartTouch‐SF catheters
Min Guo, et al. · Journal of Cardiovascular Electrophysiology · 2021
Optimal ablation settings of TactiFlex SE laser-cut irrigated-tip catheter: comparison with ThermoCool SmartTouch SurroundFlow porous irrigated-tip catheter
Kazumasa Suga, et al. · Journal of Interventional Cardiac Electrophysiology · 2024
Citations indexed from PubMed.
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