BOSTON SCIENTIFIC CORPORATION · Intravascular Ultrasound (IVUS) · First cleared Jan 2022
Total Reports
439
Reports (30d)
6
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Dark Image in Tortuous Anatomy
occurred stenosed, tortuous, lesion located, moderately, located
22
reports
Imaging Window Rippled and Dark
benchmark, rates, similar benchmark, opticross opticross, similar
6
reports
Air Not Removed During Preparation
preparation, ivus catheter, air, ivus examination, ultrasound ivus
3
reports
Catheter Kinked Near Monorail
lesion located, ultrasound ivus, located, moderately, ivus catheter
2
reports
Air Presence During Flushing
air, patient complications, selected ultrasound, flushing, preparation
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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