OptiCross Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Intravascular Ultrasound (IVUS) · First cleared Feb 2016 · 5 device variants grouped
Total Reports
1,965
Reports (30d)
45
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
87
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.
Evidence
Related research
First report of intravascular ultrasound–guided intravascular lithotripsy to treat an underexpanded stent in the superficial femoral artery
Konstantinos P. Donas, et al. · Vascular · 2021
Fundamentals and role of intravascular ultrasound in percutaneous coronary intervention
James Xu, et al. · Cardiovascular Diagnosis and Therapy · 2020
Intravascular ultrasound-guided retrieval of a fish bone embedded in the inferior vena cava: a case report
Leslye F. Conde, et al. · CVIR Endovascular · 2026
The C-CAT sign may predict coronary artery perforation in severe calcified lesions during coronary intervention: a case series
Akito Kawamura, et al. · European Heart Journal - Case Reports · 2023
Citations indexed from PubMed.
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