DECANAV Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Catheter, Electrode Recording (EP Diagnostic) · First cleared Apr 2008
Total Reports
142
Reports (30d)
6
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Pericardial Effusion from Catheter Kinking
pericardial effusion, decanav catheter, pericardial, effusion, decanav
7
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Atrioventricular nodal reentry tachycardia treatment using CARTO 3 V7 activation mapping: a new era of slow pathway radiofrequency ablation is under coming
Enrico Chieffo, et al. · Frontiers in Cardiovascular Medicine · 2023
Fluoroless and contrast-free catheter ablation without a lead apron in routine clinical practice
Takumi Matsubara, et al. · Scientific Reports · 2020
Citations indexed from PubMed.
Keep exploring
Related devices in EP Mapping
ACHIEVE
MEDTRONIC, INC. · 1,232 reports
PENTARAY NAV
Biosense Webster Inc · 595 reports
IntellaMap Orion
BOSTON SCIENTIFIC CORPORATION · 434 reports
Advisor HD Grid, Sensor Enabled
ABBOTT (ST. JUDE MEDICAL) · 414 reports
ACHIEVE ADVANCE
MEDTRONIC, INC. · 342 reports
OCTARAY Mapping Catheter
Biosense Webster Inc · 165 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.
Get Early AccessUnderstanding this data