BOSTON SCIENTIFIC CORPORATION · Cardiac Ablation Catheter for Atrial Flutter · First cleared Feb 2016
Total Reports
510
Reports (30d)
2
Active Signals
1
Open Recalls
4
What the reports describe · Claripulse analysis
Electrode Noise During Ablation Procedure
observed, left, ablation procedure, completed, mapping
5
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Nov 28, 2018 · Open, Classified
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
Nov 28, 2018 · Open, Classified
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
Nov 28, 2018 · Open, Classified
Supplier had changed its resin sub-suppliers three (3) times without notifying BSC. These changes resulted in slight variations in resin material compositions which were not reflected in BSC s internal product documentation. Not approved in customer document.
Jun 20, 2018 · Open, Classified
Reports of unintended continuation of radiofrequency (RF) energy delivery from the Cardiac ablation system after the foot switch has been released.
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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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