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

Model Number	H74939352050
Medical Device Problem Codes	Entrapment of Device (1212); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter issue occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.An opticross hd imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the catheter got stuck to the wire and could not advance further into the vessel.Both devices were removed as one unit.An alternative device was used to complete the procedure.There were no complications and the patient fully recovered.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed the sheath and imaging window were kinked.The guidewire exit port was torn, but the distal section of the tip was in good condition.
Event or Problem Description
It was reported that catheter issue occurred.The 80% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel.An opticross hd imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the catheter got stuck to the wire and could not advance further into the vessel.Both devices were removed as one unit.An alternative device was used to complete the procedure.There were no complications and the patient fully recovered.

• 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: 23782595
• Report Number: 2124215-2025-90452
• Device Sequence Number: 10144164
• Product Code: OBJ
• UDI-Device Identifier: 00191506035419
• UDI-Public: (01)00191506035419(17)260926(10)37560742
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Followup
• Report Date (Section B): 01/13/2026

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: 09/26/2026
• Device Model Number: H74939352050
• Device Catalogue Number: H74939352050
• Device Lot Number: 0037560742
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 12/11/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2025
• 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
• Patient Sex: Unknown