OptiCross 18 Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Intravascular Ultrasound (IVUS) · First cleared Sep 2022
Total Reports
200
Reports (30d)
4
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Air Not Removed with Image Loss
air, complete procedure, air removed, lesion preparation, device catheter
1
reports
Blocked Catheter with No Visualization
occurred stenosed, stenosed target, tortuous, stenosed, calcified
1
reports
Imaging Catheter Failed to Cross Lesion
based device, device analysis, analysis revealed, revealed, reportable based
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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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