BOSTON SCIENTIFIC CORPORATION · Left Atrial Appendage Closure · First cleared Mar 2015
Total Reports
1,037
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Hematoma Following Procedure
data, terms, single patient, captured separately, event terms
13
reports
Literature Batch: Vessel Trauma Event
data, terms, single patient, captured separately, event terms
9
reports
Thromboembolism Death Event
data, terms, single patient, captured separately, event terms
4
reports
Literature Batch: Unexpected Medical Intervention
data, terms, single patient, captured separately, event terms
3
reports
Literature Batch: Surgical Intervention Events
data, terms, single patient, captured separately, event terms
2
reports
Additional Device Required During Procedure
data, terms, single patient, captured separately, event terms
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
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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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