MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H7493932800180
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The 90% stenosed target lesion was located in the peripheral artery.The opticross 18 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, specifically during pullback as imaging began, the ivus catheter kinked at the midshaft and wrapped around a non boston scientific guidewire.The physician removed both the ivus catheter and the wire from the patient intact.The procedure was completed with another of the same device.The patient fully recovered, and no complications were reported.
Event or Problem Description
It was reported that a catheter issue occurred.The 90% stenosed target lesion was located in the peripheral artery.The opticross 18 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, specifically during pullback as imaging began, the ivus catheter kinked at the midshaft and wrapped around a non-boston scientific guidewire.The physician removed both the ivus catheter and the wire from the patient intact.The procedure was completed with another of the same device.The patient fully recovered, and no complications were reported.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed that the sheath assembly was kinked.Microscope inspection showed that the guidewire exit port and the distal section of the tip were in good condition.A test guidewire was inserted, and there was no indication of resistance when tracking the guidewire into the catheter.

• Brand Name: OPTICROSS 18
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24192298
• Report Number: 2124215-2026-04776
• Device Sequence Number: 8064710
• Product Code: OBJ
• UDI-Device Identifier: 08714729904366
• UDI-Public: (01)08714729904366(17)271119(10)37999421
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K160514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: H7493932800180
• Device Catalogue Number: H7493932800180
• Device Lot Number: 0037999421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2026
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HI-TORQUE SPARTACORE PERIPHERAL GUIDE WIRE.; HI-TORQUE SPARTACORE PERIPHERAL GUIDE WIRE.
• Patient Sex: Unknown