Webster CS Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Catheter, Electrode Recording (EP Diagnostic) · First cleared Apr 2008 · 7 device variants grouped
Total Reports
105
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Cardiac Tamponade from Catheter Kinking
pericardial effusion, tamponade, effusion, pericardial, pericardiocentesis
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Keep exploring
Related devices in EP Mapping
ACHIEVE
MEDTRONIC, INC. · 1,337 reports
PENTARAY NAV
Biosense Webster Inc · 1,006 reports
OCTARAY Mapping Catheter
Biosense Webster Inc · 499 reports
IntellaMap Orion
BOSTON SCIENTIFIC CORPORATION · 439 reports
Advisor HD Grid, Sensor Enabled
ABBOTT (ST. JUDE MEDICAL) · 415 reports
ACHIEVE ADVANCE
MEDTRONIC, INC. · 374 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