OptiCross 18 Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Intravascular Ultrasound (IVUS) · First cleared Sep 2022
Total Reports
196
Reports (30d)
1
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Catheter Unable to Flush
target lesion, target, examination, opticross, ultrasound examination
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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