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

Model Number	H74939352040
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a catheter issue occurred.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the post stent placement ivus run, the tip of the catheter broke off inside the patient.Computer tomography (ct) was performed but the catheter tip was not shown.There were no patient complications, and the patient was fine.
Additional Manufacturer Narrative
B3 date of event was estimated based on aware date as the event date was not reported.G4: pma/510(k) # k173284, k213593.Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.
Additional Manufacturer Narrative
B3 date of event was estimated based on aware date as the event date was not reported.G4: pma/510(k) # k173284, k213593.Good faith effort attempts were made to try and retrieve the device status, but it was unable to be obtained.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 was detached.
Event or Problem Description
It was reported that a catheter issue occurred.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the post stent placement ivus run, the tip of the catheter broke off inside the patient.Computer tomography (ct) was performed but the catheter tip was not shown.There were no patient complications, and the patient was fine.

• 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: 22420719
• Report Number: 2124215-2025-45015
• Device Sequence Number: 6979039
• Product Code: OBJ
• UDI-Device Identifier: 08714729960737
• UDI-Public: (01)08714729960737(17)260120(10)35668521
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 09/03/2025

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: 01/20/2026
• Device Model Number: H74939352040
• Device Catalogue Number: H74939352040
• Device Lot Number: 0035668521
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 09/03/2025
• Date Device Manufactured: 01/20/2025
• 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