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

Model Number	H74939352040
Medical Device Problem Codes	Poor Quality Image (1408); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket/510(k) #: k173284, k213593.
Event or Problem Description
It was reported that a catheter issue occurred.The stenosed target lesion was located in the coronary artery.The opticross hd imaging catheter was advanced for an intravascular ultrasound (ivus) examination of the target lesion.When the ivus catheter was tested prior to insertion, the image displayed non-uniform rotational distortion (nurd), and a kink was found in the catheter.It was further noted that the catheter was fractured/separated.The procedure was completed with an alternative device, and there were no patient complications.

• 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: 21766817
• Report Number: 2124215-2025-19657
• Device Sequence Number: 18311969
• Product Code: OBJ
• UDI-Device Identifier: 08714729960737
• UDI-Public: (01)08714729960737(17)251118(10)35310567
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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: 11/18/2025
• Device Model Number: H74939352040
• Device Catalogue Number: H74939352040
• Device Lot Number: 0035310567
• 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: 03/13/2025
• Initial Report FDA Received Date: 04/03/2025
• Date Device Manufactured: 11/18/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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