MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS? 6 HD; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	H74939354090
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that catheter issue occurred.The 80% stenosed target lesion was located in the severely calcified and moderately tortuous vessel.An opticross 6 hd imaging catheter was selected for ultrasound examination of the target lesion during a percutaneous coronary intervention (pci).The catheter was properly prepared, but when it was advanced into the body, difficulty was encountered and when the device was removed, the tip of the catheter fractured.The device was cut with the wire, and everything was removed together.The procedure was completed with another of the same device.There were no patient complications.
Event or Problem Description
It was reported that catheter issue occurred.The 80% stenosed target lesion was located in the severely calcified and moderately tortuous vessel.An opticross 6 hd imaging catheter was selected for ultrasound examination of the target lesion during a percutaneous coronary intervention (pci).The catheter was properly prepared, but when it was advanced into the body, difficulty was encountered and when the device was removed, the tip of the catheter fractured.The device was cut with the wire, and everything was removed together.The procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical evaluation could not be performed.However, a review of the media provided by the customer showed evidence that the tip detached.

• Brand Name: OPTICROSS? 6 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: 23918959
• Report Number: 2124215-2025-93610
• Device Sequence Number: 8824606
• Product Code: OBJ
• UDI-Device Identifier: 00191506035457
• UDI-Public: (01)00191506035457(17)270820(10)37235651
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

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: H74939354090
• Device Catalogue Number: H74939354090
• Device Lot Number: 0037235651
• 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: 12/08/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 02/16/2026
• Date Device Manufactured: 08/20/2025
• 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