ThermoCool SF NAV Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Cardiac Ablation Catheter (Percutaneous) · First cleared Dec 2011 · 8 device variants grouped
Total Reports
109
Reports (30d)
1
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Literature Batch: Atrial Fibrillation Ablation Outcomes
mentioned, qty case, background, bwi devices, intervention mentioned
3
reports
Cardiac Tamponade Post-Ablation Procedure
reportable, pebax, tubing, patient underwent, procedure thermocool
2
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Evidence
Related research
Citations indexed from PubMed.
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