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); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a catheter issue occurred.The opticross hd imaging catheter was selected for ultrasound examination in the right coronary artery (rca).The physician attempted to perform intravascular ultrasound with a 5 mm catheter.It was difficult to advance due to the tortuosity in the mid rca, but the catheter was advanced to the lesion and ivus was performed.As the physician tried to remove the catheter, it became tangled in the tortuosity in the mid rca.The catheter itself came out, but the hypotube that the catheter was advanced through sheared off on the wire in the mid rca.The physician was able to snare it out using a 4 - 8 mm snare over the wire, but all of the equipment including the guide catheter and wiggle wire had to be removed.The physician confirmed that the tip of the catheter was completely removed from the body.The procedure was completed using original method.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.Visual inspection revealed the imaging window was kinked, and the tip was detached.Microscopic inspection revealed the imaging window was pinched with ripples.Also, the guidewire exit port was observed damaged and the distal section of the tip was detached and was not returned for analysis.
Event or Problem Description
It was reported that a catheter issue occurred.The opticross hd imaging catheter was selected for ultrasound examination in the right coronary artery (rca).The physician attempted to perform intravascular ultrasound with a 5 mm catheter.It was difficult to advance due to the tortuosity in the mid rca, but the catheter was advanced to the lesion and ivus was performed.As the physician tried to remove the catheter, it became tangled in the tortuosity in the mid rca.The catheter itself came out, but the hypotube that the catheter was advanced through sheared off on the wire in the mid rca.The physician was able to snare it out using a 4 - 8 mm snare over the wire, but all of the equipment including the guide catheter and wiggle wire had to be removed.The physician confirmed that the tip of the catheter was completely removed from the body.The procedure was completed using original method.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: 23586027
• Report Number: 2124215-2025-83705
• Device Sequence Number: 9259941
• Product Code: OBJ
• UDI-Device Identifier: 00191506035419
• UDI-Public: (01)00191506035419(17)260828(10)37324250
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/30/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2026
• Device Model Number: H74939352050
• Device Catalogue Number: H74939352050
• Device Lot Number: 0037324250
• 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: 10/27/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown