SOUNDSTAR Adverse Events: FDA MAUDE Data

Biosense Webster Inc · Intravascular Ultrasound (IVUS) · First cleared Mar 2014

Total Reports

129

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Catheter Tip Fracture During Procedure

ice, soundstar, viewflex catheter, ablation, viewflex

reports

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

Detection

Active safety signals

Disproportionate reportinghigh

Evidence

Related research

Zero‐fluoroscopy transseptal puncture guided by right atrial electroanatomical mapping combined with intracardiac echocardiography: A single‐center experience

Guangping Zhang, et al. · Clinical Cardiology · 2020

Study on the Curative Effect and Safety of Radiofrequency Catheter Ablation of Paroxysmal Atrial Fibrillation via Zero-Fluoroscopy Transseptal Puncture under the Dual Guidance of Electroanatomical Mapping and Intracardiac Echocardiography

Fei Hang, et al. · Cardiology Research and Practice · 2021

Outcomes and Safety of Fluoroless Catheter Ablation for Atrial Fibrillation

Antony Lurie, et al. · CJC Open · 2020

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.