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

Model Number	H749518100
Medical Device Problem Codes	Nonstandard Device (1420); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation results: device analysis findings: the device was returned for analysis.Visual inspection revealed that the device was entangled with the guidewire cable.The catheter was twisted, and the sheath and imaging window were kinked.Microscope inspection revealed that the guidewire exit port and the distal section of the tip were in good condition; however, the imaging window was rippled.Functional testing with the guidewire could not be performed due to the guidewire entanglement.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 failure to follow instructions.During product analysis, the guidewire was found tangled with the opticross device, and the imaging window and drive cable were found twisted.Per the investigation completed as part of a capa for opticross catheter twist complaints, 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 is evidence of advancing the device into the patient anatomy 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, the difficult to cross lesion reported event is confirmed by evidence found during product analysis.
Event or Problem Description
Reportable based on device analysis completed on 12 feb 2026.It was reported that a catheter issue occurred.The stenosed target lesion was located in the severely tortuous and severely calcified left anterior descending artery.The opticross imaging catheter was advanced for ultrasound examination of the target lesion; however, it could not cross the lesion.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 device was entangled with the guidewire cable.The catheter was twisted, and the imaging window was rippled.

• 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: 24501041
• Report Number: 2124215-2026-11790
• Device Sequence Number: 13365960
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)260716(10)36988071
• 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): 03/03/2026

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: 07/16/2026
• Device Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0036988071
• 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: 02/12/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2025
• 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: 59 YR
• Patient Sex: Male