BOSTON SCIENTIFIC CORPORATION · Left Atrial Appendage Closure · First cleared Mar 2015
Total Reports
654
Reports (30d)
42
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Pericardial Effusion During Procedure
wds, pericardial effusion, pericardial, effusion, occurred
35
reports
Thrombus Detected on Follow-Up Imaging
tee, performed watchman, thrombosis, closure procedure, thrombus
20
reports
Device Migration with Peri-Device Leak
performed watchman, leak, closure procedure, procedure performed, occurred
19
reports
Thromboembolism Death Event
data, terms, single patient, captured separately, event terms
11
reports
CVA Post-Implant After Four Years
device implanted, stroke, closure procedure, occurred, discharged
7
reports
Device Related Thrombus Detected
related, reported occurred, complications, thrombus, imaging
7
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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