Biosense Webster Inc · Cardiac Ablation Catheter for Atrial Flutter
Total Reports
933
Reports (30d)
24
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
High Force Reading with Pericardial Effusion
micro, qdot micro, pericardial, effusion, qdot
57
reports
Electrode Noise During Ablation Procedure
observed, left, ablation procedure, completed, mapping
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
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
Citations indexed from PubMed.
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Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
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