MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS HD; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	8668
Medical Device Problem Codes	No Display/Image (1183); Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 02 february 2026.It was reported that visualization issues occurred.The 90% stenosed target lesion was located in a severely tortuous and severely calcified right coronary artery.The opticross hd imaging catheter was advanced for ultrasound examination of the target lesion; but the image could not be displayed.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the catheter was twisted and entangled with the guidewire, and the imaging window was rippled.
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).The device was returned for analysis.Visual inspection revealed that the sheath assembly was kinked.The catheter was observed to be twisted and entangled with the guidewire, and the imaging window was rippled.Impedance testing showed an electrical open at the distal end of the catheter, between 0 and 10 cm from the distal housing.The transducer level impedance test using the microprobe could not be performed due to the condition of the transducer/distal housing.

• Brand Name: OPTICROSS HD
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• 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: 24430557
• Report Number: 2124215-2026-10120
• Device Sequence Number: 21406930
• Product Code: OBJ
• UDI-Device Identifier: 08714729960768
• UDI-Public: (01)08714729960768(17)260911(10)37435673
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K173284
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: 09/11/2026
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0037435673
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2025
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 71 KG