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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

Back to Electrophysiology: Mapping
MAUDE LookupElectrophysiology: MappingDECANAV

DECANAV Adverse Events: FDA MAUDE Data

Biosense Webster Inc · Catheter, Electrode Recording (EP Diagnostic) · First cleared Apr 2008

Total Reports

122

Reports (30d)

1

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Pericardial Effusion Post-Ablation

right, pericardial effusion, pericardial, effusion, pericardiocentesis

5

reports

2

Catheter Tip Fracture During Procedure

completed adverse, lasso

1

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

Atrioventricular nodal reentry tachycardia treatment using CARTO 3 V7 activation mapping: a new era of slow pathway radiofrequency ablation is under coming

Enrico Chieffo, et al. · Frontiers in Cardiovascular Medicine · 2023

Fluoroless and contrast-free catheter ablation without a lead apron in routine clinical practice

Takumi Matsubara, et al. · Scientific Reports · 2020

Improvement of Renal Function in Atrial Fibrillation Patients via Catheter Ablation and Left Atrial Appendage Closure: A Case Report.

Chen J, et al. · 2025

High-density mapping for AVNRT ablation with distorted conduction system anatomy post-ASD device closure-case report.

Lahiri S, et al. · 2025

Case report of ventricular tachycardia simulation facilitated ablation for refractory ventricular arrhythmia post-myocardial infarction: aiming before firing.

Liu Z, et al. · 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.