MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS? 6 HD; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H74939354080
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that catheter issue occurred.An opticross 6 hd imaging catheter was selected for the ultrasound examination of the target lesion.During the procedure, the intravascular ultrasound (ivus) catheter wrapped around the unknown wire, making it impossible to remove the ivus catheter without also removing the interventional wire.No patient complications were reported.
Additional Manufacturer Narrative
B3: date of event: the event date was not reported.The first date of the month of the aware date was entered as an estimate.G4: premarket / 510(k) # k173820, k213593.
Additional Manufacturer Narrative
B3: date of event: the event date was not reported.The first date of the month of the aware date was entered as an estimate.G4: premarket / 510(k) # k173820, k213593.The device was returned for analysis.Visual and microscopic inspection revealed that the telescope, sheath, and imaging window were kinked.Also, the guidewire was found to be entangled with the imaging window.
Event or Problem Description
It was reported that catheter issue occurred.An opticross 6 hd imaging catheter was selected for the ultrasound examination of the target lesion.During the procedure, the intravascular ultrasound (ivus) catheter wrapped around the unknown wire, making it impossible to remove the ivus catheter without also removing the interventional wire.No patient complications were reported.

• Brand Name: OPTICROSS? 6 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: 22487491
• Report Number: 2124215-2025-45061
• Device Sequence Number: 15457851
• Product Code: OBJ
• UDI-Device Identifier: 08714729960775
• UDI-Public: (01)08714729960775(17)270203(10)35769648
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K173820
• 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): 08/29/2025

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 Model Number: H74939354080
• Device Catalogue Number: H74939354080
• Device Lot Number: 0035769648
• 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: 06/17/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2025
• 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