MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS? 6; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	H7495181360
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred and the vessel was occluded.The 90% stenosed target lesion as located in the moderately tortuous and mildly calcified left anterior descending artery (lad).The opticross 6 imaging catheter was advanced for ultrasound examination of the target lesion.Following stenting, the opticross was advanced again, but was difficult to remove and vessel occlusion was noted.The opticross and guidewire were removed together, and the wire broke in the mid-section.The vessel was ballooned and the procedure continued and the lad was successfully opened.The patient fully recovered.

• Brand Name: OPTICROSS? 6
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• 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: 23533475
• Report Number: 2124215-2025-82149
• Device Sequence Number: 18426992
• Product Code: OBJ
• UDI-Device Identifier: 00191506035433
• UDI-Public: (01)00191506035433(17)270808(10)37166822
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: K213593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2025

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 Model Number: H7495181360
• Device Catalogue Number: H7495181360
• Device Lot Number: 0037166822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 11/12/2025
• Date Device Manufactured: 08/08/2025
• 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 Age: 66 YR
• Patient Sex: Female
• Patient Weight: 41 KG