BOSTON SCIENTIFIC CORPORATION · Intravascular Ultrasound (IVUS) · First cleared Sep 2022
Total Reports
192
Reports (30d)
0
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Catheter Kinked Near Monorail
lesion located, ultrasound ivus, located, moderately, ivus catheter
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Regulatory
Mar 5, 2024 · Open, Classified
Certain batches of Opticross 40MHz Coronary Imaging Catheters manufactured using an incorrect voltage setting, which may have resulted in decreased image brightness.
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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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