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IntellaMap Orion Adverse Events: FDA MAUDE Data

BOSTON SCIENTIFIC CORPORATION · Catheter, Electrode Recording (EP Diagnostic) · First cleared Oct 2019

Total Reports

439

Reports (30d)

5

Active Signals

0

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Packaging Defect Causing Catheter Breakage

achieve, replacement, material, replaced procedure, packaging

6

reports

2

Cardiac Tamponade from Catheter Kinking

pericardial effusion, tamponade, effusion, pericardial, pericardiocentesis

5

reports

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

Evidence

Related research

Ultra-high-resolution assessment of lesion extension after cryoballoon ablation for pulmonary vein isolation

Francesco Raffaele Spera, et al. · Frontiers in Cardiovascular Medicine · 2022

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.