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

Model Number	H749518100
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	01/15/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: device analysis: the device was returned for analysis.Visual and microscopic inspections revealed that the sheath assembly was kinked, and an imaging core break involving the drive and coaxial cable was identified, beginning 28.4 cm from the distal end of the connector shaft.The imaging window was rippled, and the imaging core was entangled.Impedance testing showed an electrical open at the proximal end.The sheath of the unit was cut a few centimeters below the severe kink to allow inspection of the other end of the broken imaging core.Device history record (dhr) review: it was confirmed that this device met manufacturing specifications before distribution and there were no manufacturing deviations that 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.Conclusion: this investigation has been assigned an investigation conclusion code of failure to follow instructions.The observed twisting and imaging window ripples are consistent with advancing the device while rotating.According to the instructions for use, the motor drive unit, which provides the rotation, should remain off during insertion.
Event or Problem Description
Reportable based on device analysis completed on (b)(6) 2026.It was reported that visualization issues occurred.The 85% stenosed target lesion was located in a moderately tortuous and severely calcified left anterior descending artery.The opticross imaging catheter was advanced for ultrasound examination of the target lesion; however, the image was lost.The procedure was completed with another of the same device.The patients condition was good, and no complications were reported.However, device analysis revealed that the imaging window was rippled and the imaging core was entangled.

• 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: 24800529
• Report Number: 2124215-2026-18763
• Device Sequence Number: 9548282
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)261121(10)38024204
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K123621
• 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): 04/07/2026

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 Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0038024204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2026
• Initial Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2025
• 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: 61 YR
• Patient Sex: Female