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

Model Number	8655
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The target lesion was located in the left circumflex artery (lcx) and left anterior descending (lad) artery.An opticross imaging catheter was advanced for ultrasound examination of the target lesions.The opticross catheter was first used in the lcx and a stent was finely deployed.The opticross catheter was then inserted to lad.The operator felt the catheter was stuck when crossing the lesion but continued to apply force until the catheter bent and snaped.The device was removed, and no patient complications were reported.
Event or Problem Description
It was reported that a catheter issue occurred.The target lesion was located in the left circumflex artery (lcx) and left anterior descending (lad) artery.An opticross imaging catheter was advanced for ultrasound examination of the target lesions.The opticross catheter was first used in the lcx and a stent was finely deployed.The opticross catheter was then inserted to lad.The operator felt the catheter was stuck when crossing the lesion but continued to apply force until the catheter bent and snapped.The device was removed, and no patient complications were reported.

• 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: 21434914
• Report Number: 2124215-2025-09490
• Device Sequence Number: 17271329
• Product Code: OBJ
• UDI-Device Identifier: 08714729841531
• UDI-Public: 08714729841531
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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: 04/08/2025
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0033780453
• Was Device Available for Evaluation?: No
• 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: 05/05/2025
• Initial Report FDA Received Date: 02/21/2025
• Supplement Report FDA Received Date: 05/09/2025
• Date Device Manufactured: 04/08/2024
• 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: 70 YR
• Patient Sex: Male