ThermoCool SmartTouch Adverse Events: FDA MAUDE Data

Biosense Webster Inc · Cardiac Ablation Catheter (Percutaneous) · First cleared Nov 2004 · 8 device variants grouped

Total Reports

1,177

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Cardiac Tamponade Post-Ablation Procedure

reportable, pebax, tubing, patient underwent, procedure thermocool

reports

Literature Batch: Atrial Fibrillation Ablation Outcomes

mentioned, qty case, background, bwi devices, intervention mentioned

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

Radiofrequency ablation using the ThermoCool SmartTouch Catheter guided by ablation index versus antiarrhythmic drugs in atrial fibrillation treatment in China: a cost-consequence analysis.

Zhang B, et al. · Journal of comparative effectiveness research · 2024

Tied up in the Lab: An Unexpected Catheter Knot in the Arterial System.

Arya AK, et al. · Pacing and clinical electrophysiology : PACE · 2026

The Feasibility, Safety and Outcome of Very High-Power Short Duration Radiofrequency Ablation in Pulmonary Vein Isolation: A Real-World Observation Study.

Mavilakandy A, et al. · Reviews in cardiovascular medicine · 2024

Citations indexed from PubMed.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

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How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

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Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.