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

Model Number	8655
Medical Device Problem Codes	No Display/Image (1183); Image Display Error/Artifact (1304); 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
Additional Manufacturer Narrative
B3 date of event 09/01/2025 used as approximate date as actual date is unknown.
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 proximal 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
B3 date of event 09/01/2025 used as approximate date as actual date is unknown.Correction to h6 device codes.
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 proximal part, and no image could be obtained.A different device was used to successfully complete the procedure.There were no patient complications.
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 proximal 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
B3 date of event 09/01/2025 used as approximate date as actual date is unknown.Correction to h6 device codes device evaluation by mfr: the returned product consisted of the opticross imaging catheter.A visual inspection revealed the sheath assembly was kinked.The hub rotator retainer clip was removed and it was revealed that the drive and coaxial cable were broken beginning from 26.3cm from the distal end of the connector shaft.An impedance test showed open.Regarding the electrical failure found, an open circuit was identified at the proximal end of the catheter, which is related to a breakage of the coaxial cable.This occurs due to the material characteristics of the coaxial cable and the drive cable, since the drive cable is made of counter-winded coils, it has better elastic capabilities than the wires used to transmit energy to the transducer (coaxial cable).The drive cable can elongate under tension further than what the coaxial cable is capable of, and if a certain threshold is exceeded, the coaxial cable will break.Consequently, the device will not be able to display an image.This condition could happen especially during the telescope action when constriction is experienced over the catheter.In some cases, the drive cable could also be broken when the catheter is exposed to higher constrictions.Failures related to this issue are traced to the design characteristics of the device.However, it was noticed that the sheath was kinked.A kink causes a change in the inner diameter, which can significantly increase the constriction over the catheter.Regarding 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.

• 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: 23372177
• Report Number: 2124215-2025-75133
• Device Sequence Number: 12981643
• Product Code: OBJ
• UDI-Device Identifier: 08714729841531
• UDI-Public: (01)08714729841531(17)260524(10)36601070
• 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,Followup
• Report Date (Section B): 01/16/2026

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: 11/17/2025; 12/22/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/12/2025; 01/16/2026
• 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