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

Model Number	8655
Medical Device Problem Codes	No Display/Image (1183); Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the catheter fractured.An opticross imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the catheter broke at the distal part, and no image could be obtained.A different device was used to successfully complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
The returned product consisted of the opticross catheter.A visual inspection showed the sheath was kinked.Under microscopic inspection the imaging core was found to be stretched.An impedance test showed an open distal waveform.Egarding the observed kinked sheath, this type of failure could occur during procedure inside the patient during the advancement maneuvers, since in this process, the friction between the catheter, the hemostasis valve, guide catheter and the lesion creates a force that opposes the movement of the catheter; and/or during procedure outside the patient due to the action of external forces over the catheter, usually related to the handling of the device.Regarding the stretched imaging window, the dhr review confirmed that the device met all manufacturing specifications.Therefore, it is most probable that the observed imaging window stretching occurred during the procedure due to user manipulation.As the detachment could not be confirmed, this investigation has been assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported that the catheter fractured.An opticross imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the catheter broke at the distal part, and no image could be obtained.A different device was used to successfully complete the procedure.There were no patient complications.

• 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: 23372176
• Report Number: 2124215-2025-75134
• Device Sequence Number: 18362713
• Product Code: OBJ
• UDI-Device Identifier: 08714729841531
• UDI-Public: (01)08714729841531(17)260524(10)36601073
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• 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): 02/03/2026

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: 05/24/2026
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0036601070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2025
• Supplement Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2025
• 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
• Patient Sex: Unknown