IntellaMap Orion Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Catheter, Electrode Recording (EP Diagnostic) · First cleared Oct 2019
Total Reports
434
Reports (30d)
5
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Broken Mapping Catheter Before Procedure
broken, cryo, cryo ablation, electrodes, removal
4
reports
Pericardial Effusion from Catheter Kinking
pericardial effusion, decanav catheter, pericardial, effusion, decanav
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Ablation of visually identified spatiotemporal dispersion plus pulmonary vein isolation in persistent atrial fibrillation
Eduardo Franco, et al. · European Heart Journal Open · 2026
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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