OptiCross Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Intravascular Ultrasound (IVUS) · First cleared Feb 2016
Total Reports
1,288
Reports (30d)
35
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Dark Screen During Imaging
issue occurred, target lesion, examination, imaging catheter, opticross
75
reports
Catheter Unable to Flush
target lesion, target, examination, opticross, ultrasound examination
42
reports
Twisted Catheter During Imaging
reportable, target lesion, device analysis, analysis revealed, reportable based
3
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
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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