SOUNDSTAR Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Intravascular Ultrasound (IVUS) · First cleared May 2007 · 6 device variants grouped
Total Reports
407
Reports (30d)
3
Active Signals
2
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Catheter Distal Tip Fracture
journal, study, philips volcano, journal article, listed
2
reports
Imaging Catheter Tip Blockage
opticross imaging, examination target, issue occurred, imaging catheter, opticross
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
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
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
Fluoroless and contrast-free catheter ablation without a lead apron in routine clinical practice
Takumi James Matsubara, et al. · Scientific Reports · 2020
Artificial intelligence-intracardiac echocardiography-guided pulsed field ablation of atrial fibrillation with variable-loop circular catheter
Fengwei Zou, et al. · EP Europace · 2026
AI-Assisted 3D Intracardiac Echocardiography for Pulsed Field Ablation of Atrial Fibrillation Using a Novel Variable Loop Circular Catheter: A Multicenter Evaluation
Antonio Dello Russo, et al. · Journal of Clinical Medicine · 2025
Citations indexed from PubMed.
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