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	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket / 510(k) # k160514, k222568.
Event or Problem Description
A catheter issue was reported during the procedure.The 90% stenosed target lesion was located in a limited tortuous, and mildly calcified mid superficial femoral artery (sfa).An opticross 18 imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the catheter deployed to position but wrapped around a non-boston scientific (non-bsc) wire during recording pullback.The catheter was then pulled out along with the non-bsc wire.The procedure was completed using an alternate device.No patient complications.
Additional Manufacturer Narrative
G4: premarket / 510(k) # k160514, k222568.The device was returned for analysis.Visual inspection revealed no issues, and the device appeared to be in good condition.The non-boston scientific guidewire was not returned for analysis.Microscopic inspection revealed that the guidewire exit port was lifted, but the distal section of the tip was in good condition.A test guidewire was inserted, and there was no indication of resistance when tracking the guidewire into the catheter.
Event or Problem Description
A catheter issue was reported during the procedure.The 90% stenosed target lesion was located in a limited tortuous, and mildly calcified mid superficial femoral artery (sfa).An opticross 18 imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the catheter deployed to position but wrapped around a non-boston scientific (non-bsc) wire during recording pullback.The catheter was then pulled out along with the non-bsc wire.The procedure was completed using an alternate device.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: 22393939
• Report Number: 2124215-2025-43958
• Device Sequence Number: 18423624
• Product Code: OBJ
• UDI-Device Identifier: 08714729904366
• UDI-Public: (01)08714729904366(17)270326(10)36158498
• 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: 0036158498
• 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: 06/12/2025
• 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: 03/26/2025
• 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: SPARTACORE WIRE.; SPARTACORE WIRE.
• Patient Sex: Unknown