OptiCross HD Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Intravascular Ultrasound (IVUS) · First cleared Jan 2022
Total Reports
524
Reports (30d)
21
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Blocked Catheter with No Visualization
occurred stenosed, stenosed target, tortuous, stenosed, calcified
25
reports
Imaging Catheter Failed to Cross Lesion
based device, device analysis, analysis revealed, revealed, reportable based
11
reports
Air Not Removed with Image Loss
air, complete procedure, air removed, lesion preparation, device catheter
5
reports
Air Not Removed During Preparation
air, air removed, selected intravascular, noted air, ultrasound ivus
4
reports
Aborted Procedure Due to Device Failure
resulting aborted, ivus examination, aborted procedure, main, ultrasound ivus
2
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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