NaviStar ThermoCool Adverse Events: FDA MAUDE Data
Biosense Webster Inc · Cardiac Ablation Catheter for Atrial Flutter · First cleared Nov 2004
Total Reports
145
Reports (30d)
1
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Inconsistent Irrigation Flow with Overheating
observed, temperature, high, completed, used
1
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.
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