DECANAV Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Catheter, Electrode Recording (EP Diagnostic) · First cleared Apr 2008
Total Reports
131
Reports (30d)
5
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Damaged Catheter Tip During Atrial Flutter Ablation
catheter exchanged, exchanged, pacing wire, procedure decanav, internal
6
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Keep exploring
Related devices in EP Mapping
ACHIEVE
MEDTRONIC, INC. · 1,222 reports
PENTARAY NAV
Biosense Webster Inc · 571 reports
IntellaMap Orion
BOSTON SCIENTIFIC CORPORATION · 423 reports
Advisor HD Grid, Sensor Enabled
ABBOTT (ST. JUDE MEDICAL) · 411 reports
ACHIEVE ADVANCE
MEDTRONIC, INC. · 339 reports
OCTARAY Mapping Catheter
Biosense Webster Inc · 160 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
Get Early AccessUnderstanding this data