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

Model Number	8655
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).
Event or Problem Description
It was reported that a catheter issue occurred.An opticross catheter was selected for the ultrasound examination of the target lesion.The packaging indicated it was an opticross 40 mhz catheter; however, upon connection, the system recognized it as an opticross 18 (30 mhz) catheter intended for peripheral use.The procedure was continued using the opticross 18, and no patient complications were reported.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).The device was not returned for analysis; therefore, a technical analysis could not be performed on the device.However, a review of media provided by the customer showed a catheter misrecognition issue but did not show enough evidence to identify a device defect which could have contributed to the reported issue.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross catheter was selected for the ultrasound examination of the target lesion.The packaging indicated it was an opticross 40 mhz catheter; however, upon connection, the system recognized it as an opticross 18 (30 mhz) catheter intended for peripheral use.The procedure was continued using the original device, and no patient complications were reported.It was further reported that the target lesion with 80 - 90% stenosed was located in a mildly tortuous and severely calcified vessel.

• 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: 23531278
• Report Number: 2124215-2025-79587
• Device Sequence Number: 9020848
• Product Code: OBJ
• UDI-Device Identifier: 08714729841531
• UDI-Public: (01)08714729841531(17)251129(10)35389454
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/29/2025
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0035389454
• 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: 10/19/2025
• Supplement Date Received by Manufacturer: 11/13/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 12/08/2025
• Date Device Manufactured: 11/29/2024
• 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
• Patient Age: 64 YR
• Patient Sex: Unknown