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

Model Number	8668
Medical Device Problem Codes	No Display/Image (1183); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was returned for analysis.Visual and microscopic inspection revealed that the sheath and the catheter was twisted.A broken drive and coaxial cable began 26 cm from the distal end of the connector shaft.The guidewire returned within the device.Impedance testing showed an electrical open at the proximal end of the catheter.The sheath of the unit is cut a few centimeters below the severe kink to be able to check the other end of the broken imaging core.Device history record (dhr) review: it was confirmed that this device met manufacturing specification prior to distribution and there no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Investigation conclusion: this investigation has been assigned an investigation conclusion code of adverse event related to patient condition for the reporting imaging issue.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.This constriction could lead to the friction that caused the broken drive and coax cable.It was identified that the increased torque transmission and torque strength of the hubble drive cable leads to high enough torque build up in the event of an imaging window kink to cause a twist event, only when the catheter is advanced with the motor drive unit (mdu) on into the patient.The material twisted found on analysis is evidence of advancing the device into patient while rotating.According to the instructions for use (ifu) indications, the mdu shall remain off when inserting the device into the patient.Based on this, failure to follow instructions is the assigned cause code of the imaging window twisted.
Event or Problem Description
Reportable based on device analysis completed on 26feb2026.It was reported that visualization issues occurred.The 80% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending (lad) artery.An opticross hd imaging catheter was selected for ultrasound examination of the target lesion but could not show the image.The procedure was completed with another of same device.No patient complications were reported.However, device analysis revealed that the catheter was twisted.

• Brand Name: OPTICROSS HD
• 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: 24641360
• Report Number: 2124215-2026-15271
• Device Sequence Number: 9876809
• Product Code: OBJ
• UDI-Device Identifier: 08714729960768
• UDI-Public: (01)08714729960768(17)260718(10)37007168
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K173284
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/19/2026

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: 07/18/2026
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0037007168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2025
• 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 Age: 82 YR
• Patient Sex: Male