PENTARAY NAV Adverse Events: FDA MAUDE Data

Biosense Webster Inc · Intracardiac Mapping Catheter, High-Density · First cleared Mar 2013

Total Reports

549

Reports (30d)

Active Signals

Open Recalls

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

Irrigation Failure with Second Device Used

second device, luer hub, device including, water, port luer

reports

Irrigation Failure with Effusion Risk

sheath, octaray mapping, effusion, octaray, blood

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 reportinghighIncreasing trendcritical

Evidence

Related research

Notable Pacemaker Shift in the Sinoatrial Node After Administration of Isoproterenol

Kohei Iwasa, et al. · Canadian Journal of Cardiology · 2022

Zero-fluoroscopy transseptal puncture guided by right atrial high-density precision mapping.

Lu J, et al. · 2024

First clinical experience using a visualized sheath for atrial fibrillation ablation

Moneeb Khalaph, et al. · Pacing and Clinical Electrophysiology · 2022

Long-Term Outcomes of Catheter Ablation in Ventricular Tachycardia Electrical Storm: A Retrospective Cohort Study.

Çöteli C, et al. · 2025

Non-Endocardial Radiofrequency Ablation of Premature Ventricular Complexes (NERA-PVC): Safety, Efficacy and Outcome.

Falzone PV, 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.