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

Model Number	H7493932800180
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k222568.
Event or Problem Description
It was reported that a catheter issue occurred.The 90% stenosed target lesion was located in the superficial femoral artery (sfa).The opticross 18 imaging catheter was advanced for an intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the device wrapped around with a non-boston scientific guidewire and needed to be removed entirely.The procedure completed using an alternate method.There were no patient complications.
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k222568.Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed the imaging window was kinked.Microscopic inspection revealed the guidewire exit port was lifted but the distal section of the tip was in good condition.The functional test showed a test guidewire was inserted, and no indication of resistance in tracking the guidewire into the catheter was noted.
Event or Problem Description
It was reported that a catheter issue occurred.The 90% stenosed target lesion was located in the superficial femoral artery (sfa).The opticross 18 imaging catheter was advanced for an intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the device wrapped around with a non-boston scientific guidewire and needed to be removed entirely.The procedure completed using an alternate method.There were no patient complications.

• 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: 22399162
• Report Number: 2124215-2025-42360
• Device Sequence Number: 20040178
• Product Code: OBJ
• UDI-Device Identifier: 08714729904366
• UDI-Public: (01)08714729904366(17)270327(10)36163135
• 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): 08/13/2025

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: 0036163135
• 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: 06/10/2025
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2025
• 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