BOSTON SCIENTIFIC CORPORATION · Intravascular Ultrasound (IVUS) · First cleared Feb 2016
Total Reports
1,225
Reports (30d)
68
Active Signals
2
Open Recalls
1
What the reports describe · Claripulse analysis
Dark Image in Tortuous Anatomy
occurred stenosed, tortuous, lesion located, moderately, located
49
reports
Air Presence During Flushing
air, patient complications, selected ultrasound, flushing, preparation
45
reports
Air Not Removed During Preparation
preparation, ivus catheter, air, ivus examination, ultrasound ivus
19
reports
Dark Image During Preparation Phase
air, dark, examination preparation, flushing, preparation
13
reports
Imaging Window Rippled and Dark
benchmark, rates, similar benchmark, opticross opticross, similar
5
reports
Catheter Kinked Near Monorail
lesion located, ultrasound ivus, located, moderately, ivus catheter
3
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. 2 active signals detected right now.
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