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	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.
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 coronary artery.An opticross hd imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the guidewire became trapped in the catheter and both were removed together.The guidewire was able to be separated from the catheter outside the patient.The procedure was completed using another method without any patient complications.
Additional Manufacturer Narrative
Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.The device was returned for analysis.Visual and microscopic inspection revealed the sheath was kinked and the guidewire exit port was damage.A test guidewire was inserted, and there was no indication of resistance when tracking the guidewire into the catheter.
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 coronary artery.An opticross hd imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the guidewire became trapped in the catheter and both were removed together.The guidewire was able to be separated from the catheter outside the patient.The procedure was completed using another method without any patient complications.

• 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: 23766441
• Report Number: 2124215-2025-90066
• Device Sequence Number: 9743192
• Product Code: OBJ
• UDI-Device Identifier: 00191506035419
• UDI-Public: (01)00191506035419(17)260829(10)37334256
• 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): 01/07/2026

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: 08/29/2026
• Device Model Number: H74939352050
• Device Catalogue Number: H74939352050
• Device Lot Number: 0037334256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 01/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ASAHI GUIDEWIRE; ASAHI GUIDEWIRE
• Patient Sex: Unknown