OptiCross 6 HD Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Intravascular Ultrasound (IVUS) · First cleared Jan 2022 · 3 device variants grouped
Total Reports
322
Reports (30d)
10
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Imaging Catheter Tip Blockage
opticross imaging, examination target, issue occurred, imaging catheter, opticross
20
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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