MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS? HD; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	H74939352050
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	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code (product code) itx, obj.Detailed product information was not provided to bsc.The unique device identifier (udi) could not be completed as the batch/lot number was not available.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a catheter issue occurred.The approximately 70 - 80% stenosed target lesion was located in a very tortuous and moderately calcified right coronary artery (rca).A 5fr opticross hd imaging catheter was selected for ultrasound examination of the target lesion post stent placement.During the procedure, the catheter became kinked and could not be removed over the non-boston scientific (non-bsc) guidewire.Both the catheter and the wire were removed together, and the physician applied significant force to extract them from the radial sheath.The procedure was completed using an alternative method, and no patient complications were reported.

• Brand Name: OPTICROSS? HD
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• 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: 22743402
• Report Number: 2124215-2025-53317
• Device Sequence Number: 8385935
• Product Code: ITX
• UDI-Device Identifier: 00191506035419
• UDI-Public: (01)00191506035419
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K213593
• 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
• Report Date (Section B): 08/07/2025

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: H74939352050
• Device Catalogue Number: H74939352050
• 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: 07/16/2025
• Initial Report FDA Received Date: 08/07/2025
• 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