ThermoCool SmartTouch SF Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Cardiac Ablation Catheter (Percutaneous) · First cleared Nov 2004 · 10 device variants grouped
Total Reports
5,860
Reports (30d)
25
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
64
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Acute and mid-term outcomes of ablation for atrial fibrillation with VISITAG SURPOINT: the Japan MIYABI registry
Ken Okumura, et al. · EP Europace · 2023
Dual energy for pulmonary vein isolation using focal ablation technology integrated with a three-dimensional mapping system: SmartfIRE 12-month results
Tom De Potter, et al. · EP Europace · 2025
Persistent Atrial Fibrillation Ablation With Contact Force–Sensing Catheter
Moussa Mansour, et al. · JACC. Clinical electrophysiology · 2020
Safety and effectiveness of very-high-power, short-duration ablation in patients with atrial fibrillation: Preliminary results
Karolina Mitrzak, et al. · Cardiology Journal · 2023
Superior vena cava isolation with 50 W high power, short duration ablation strategy
Shigeki Kusa, et al. · Journal of Cardiovascular Electrophysiology · 2021
Citations indexed from PubMed.
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