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

Model Number	H74939352050
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
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
B3: date of event: the event date was unknown.The first date of the month of the aware date was entered as an estimate.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 hd imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the catheter was separated from the sheath.No patient complications were reported.
Additional Manufacturer Narrative
B3: date of event: the event date was unknown.The first date of the month of the aware date was entered as an estimate.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.The device was returned for analysis.Visual inspection revealed no issues were found and the device appeared to be in good condition.Microscopic inspection revealed the guidewire exit port was damaged and the distal tip was damaged and partially detached.A test guidewire was inserted and no indication of resistance in tracking the guidewire into the catheter was noted.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross hd imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the catheter was separated from the sheath.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: 23968890
• Report Number: 2124215-2026-00491
• Device Sequence Number: 18111685
• Product Code: OBJ
• UDI-Device Identifier: 00191506035419
• UDI-Public: (01)00191506035419(17)261010(10)37676176
• 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): 02/03/2026

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 Model Number: H74939352050
• Device Catalogue Number: H74939352050
• Device Lot Number: 0037676176
• 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: 12/11/2025
• Supplement Date Received by Manufacturer: 01/28/2026
• Initial Report FDA Received Date: 01/05/2026
• Supplement Report FDA Received Date: 02/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2025
• 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