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	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial healthcare facility - (b)(6).G4: premarket / 510(k) #: k160514, k222568.
Event or Problem Description
It was reported that the guidewire entanglement occurred.The target lesion was located in the superficial femoral artery (sfa).An opticross 18 was advanced over a non-boston scientific 018 guidewire, and images were taken in the sfa and inside the stent in the sfa.While imaging, the catheter became wrapped around the guidewire during advancement.As a result, the guidewire and ivus catheter had to be withdrawn due to entanglement.The procedure was completed using with another non-boston scientific guidewire and another of the same opticross device.There were no patient complications.
Event or Problem Description
It was reported that the guidewire entanglement occurred.The target lesion was located in the superficial femoral artery (sfa).An opticross 18 was advanced over a non-boston scientific 018 guidewire, and images were taken in the sfa and inside the stent in the sfa.While imaging, the catheter became wrapped around the guidewire during advancement.As a result, the guidewire and ivus catheter had to be withdrawn due to entanglement.The procedure was completed using with another non-boston scientific guidewire and another of the same opticross device.There were no patient complications.
Additional Manufacturer Narrative
E1: initial healthcare facility - (b)(6).G4: premarket / 510(k) #: k160514, k222568.The device was returned for analysis.Upon overall visual inspection, it was identified that a guidewire was lodged within the device.A twist was observed in the imaging window assembly, and both the guidewire exit port and the tip were found to be damaged (deformed/lifted).Based on the evidence collected, the as reported code "guidewire entanglement" is confirmed.The damage to the exit port and tip, along with the twist in the imaging window assembly discovered during product analysis, likely contributed to the reported issue.

• 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 MA ; CS
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21424978
• Report Number: 2124215-2025-08157
• Device Sequence Number: 7764369
• Product Code: OBJ
• UDI-Device Identifier: 08714729904366
• UDI-Public: (01)08714729904366(17)250525(10)31697329
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 04/24/2025

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 Expiration Date: 05/25/2025
• Device Model Number: H7493932800180
• Device Catalogue Number: H7493932800180
• Device Lot Number: 0031697329
• 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: 01/27/2025
• Supplement Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/26/2023
• 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: GUIDEWIRE: GLADIUS 018; GUIDEWIRE: GLADIUS 018
• Patient Sex: Unknown