VARIPULSE Bi-Directional Catheter Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Cardiac Ablation Catheter (Pulsed Field/PFA) · First cleared Nov 2024
Total Reports
553
Reports (30d)
33
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Cerebral Infarction with Varipulse Catheter
varipulse, directional catheter, cerebral infarction, varipulse directional, varipulse catheter
50
reports
Cardiac Tamponade Requiring Pericardiocentesis
varipulse, tamponade, directional catheter, varipulse catheter, pericardiocentesis
19
reports
Induced Ventricular Fibrillation During Ablation
ventricular, rhythm, event cardiac, sinus rhythm, radiofrequency
1
reports
Patient Death Following Ablation Complications
bsc, farawave, patients, farawave catheter, pfa
1
reports
Substance on Catheter Resistance Knob
wire, handle, white, sphere, substance
1
reports
Temperature Sensor Fault During Procedure
event cardiac, temperature, error, resolved issue, completed cardiac
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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