OCTARAY Mapping Catheter Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Intracardiac Mapping Catheter, High-Density · First cleared Jul 2020
Total Reports
160
Reports (30d)
3
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Irrigation Failure During Atrial Fibrillation Ablation
procedure octaray, octaray catheter, octaray mapping, vizigo, octaray
7
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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