PENTARAY NAV Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Intracardiac Mapping Catheter, High-Density · First cleared Mar 2013
Total Reports
571
Reports (30d)
8
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Irrigation Failure with No Water Flow
pentaray, nav catheter, procedure pentaray, water, pentaray nav
17
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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