MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	8655
Medical Device Problem Codes	No Display/Image (1183); Difficult to Flush (1251); Air/Gas in Device (4062)
Health Effect - Clinical Codes	Air Embolism (1697); Non specific EKG/ECG Changes (1817); Reduced Blood Flow (4598)
Date of Event	09/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an imaging issue and patient complications occurred.The opticross imaging catheter was advanced for an intravascular ultrasound (ivus) examination of the target lesion.During the procedure, no image was visible during ivus, and resistance was noted during flushing.The ivus device appeared to be entraining air into the catheter, which resulted in st elevation and slow reflow down the coronary artery due to probable air embolization.There were no patient complications.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.

• Brand Name: OPTICROSS
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 23638228
• Report Number: 2124215-2025-84995
• Device Sequence Number: 9917925
• Product Code: OBJ
• UDI-Device Identifier: 08714729841531
• UDI-Public: (01)08714729841531(17)260721(10)37003677
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/21/2026
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0037003677
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 11/24/2025
• Date Device Manufactured: 07/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown