NaviStar ThermoCool Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Cardiac Ablation Catheter for Atrial Flutter · First cleared Nov 2004 · 5 device variants grouped
Total Reports
198
Reports (30d)
2
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Inconsistent Irrigation Flow During Ablation
observed, thermocool, ablation procedure, patients, study
6
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Sep 7, 2022 · Open, Classified
Manufacturing error resulted in potential contamination of Bi-Directional navigation catheter irrigation path with cellulose fibers that can cause 1) Failure of initial flushing inspection, 2) Insufficient irrigation causing catheter tip temperature increase, limiting the ability to deliver ablation, or 3) particles flushed through the catheter irrigation may have thrombogenic/toxic effect.
Evidence
Related research
Composite Index Tagging for PVI in Paroxysmal AF
Luigi Di Biase, et al. · JACC. Clinical electrophysiology · 2022
Transcatheter options for atrial fibrillation treatment: an overview of the ablative techniques currently available and future perspectives
Diego Penela, et al. · Annals of Cardiothoracic Surgery · 2024
Citations indexed from PubMed.
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