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

Model Number	H749518100
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	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: (b)(6).Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross catheter was selected for the ultrasound examination of the target lesion.During insertion, the tip of the catheter was not smooth, got stuck on the stent, and could not be pulled out.The issue was resolved and procedure completed with another of same device.No patient complications were reported and the patient was stable following the procedure.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).B1: adverse event/product problem - corrected.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross catheter was selected for the ultrasound examination of the target lesion.During insertion, the tip of the catheter was not smooth, got stuck on the stent, and could not be pulled out.The issue was resolved and the procedure completed with another of same device.No patient complications were reported, and the patient was stable following the procedure.It was further reported that the target lesion had a 60% stenosis and was located in the mildly tortuous and mildly calcified left anterior descending artery.The device was released by gently moving it forward and backward.The stent was a non-boston scientific (non-bsc) device and was not damaged; however, the catheter tip had a small burr.

• 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: 23908580
• Report Number: 2124215-2025-93455
• Device Sequence Number: 9964198
• Product Code: OBJ
• UDI-Device Identifier: 08714729890393
• UDI-Public: (01)08714729890393(17)261013(10)37692268
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K123621
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H749518100
• Device Catalogue Number: H749518100
• Device Lot Number: 0037692268
• 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: 12/04/2025
• Supplement Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/10/2026
• Date Device Manufactured: 10/13/2025
• 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 Age: 67 YR
• Patient Sex: Female
• Patient Weight: 61 KG