SOUNDSTAR Adverse Events: FDA MAUDE Data

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

Total Reports

136

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Catheter Fracture with No Consequences

adverse, catheter replaced, soundstar, effusion, consequences

reports

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

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

Intracardiac Echocardiography for Procedural Guidance of Left Atrial Appendage Occlusion From Right Atrium: A Subgroup From a Multicenter Randomized Controlled Trial With Two Intracardiac Echocardiography Imaging Systems

Bijun Huang, et al. · Journal of Cardiovascular Electrophysiology · 2026

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

Intracardiac vs Transesophageal Echocardiography in Atrial Fibrillation Ablation

Xiaofeng Hu, et al. · JAMA Cardiology · 2025

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.