ThermoCool SmartTouch SF Adverse Events: FDA MAUDE Data

Biosense Webster Inc · Cardiac Ablation Catheter (Percutaneous) · First cleared Aug 2016 · 10 device variants grouped

Total Reports

5,902

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

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

Changepointhigh

Evidence

Related research

Acute procedural safety of the latest radiofrequency ablation catheters in atrial fibrillation ablation: Data from a large prospective ablation registry

Hirofumi Arai, et al. · Journal of Cardiovascular Electrophysiology · 2024

Acute and mid-term outcomes of ablation for atrial fibrillation with VISITAG SURPOINT: the Japan MIYABI registry

Ken Okumura, et al. · EP Europace · 2023

Persistent Atrial Fibrillation Ablation With Contact Force–Sensing Catheter

MOUSSA C. 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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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.