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

Model Number	H74939354080
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012); Poor Visibility (4072)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G4 premarket / 510(k) #: k213593.
Event or Problem Description
It was reported that a catheter issue occurred.The stenosed target lesion was located in the left anterior descending artery.The opticross 6 hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.After a successful stenting procedure, when the physician attempted to remove the ivus catheter, resistance was encountered.Pressure was applied to withdraw the device, and upon removal, it was noted that the radiopaque marker and distal tip had sheared off.The location was initially unclear, as the marker was not visible on fluoroscopy.During continued intervention, the radiopaque marker was observed in the left main coronary artery.Attempts were made to balloon distal and drag it out with a semi-inflated balloon; however, the final approach was to stent it into the vessel wall.The procedure was completed with an alternate device, and no patient complications were reported.
Additional Manufacturer Narrative
G4 premarket / 510(k) #: k213593.Visual inspection revealed the telescope was kinked and the tip was kinked and detached.The tip was not returned.Microscopic and media inspection revealed the tip was kinked, detached, and torn.
Event or Problem Description
It was reported that a catheter issue occurred.The stenosed target lesion was located in the left anterior descending artery.The opticross 6 hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.After a successful stenting procedure, when the physician attempted to remove the ivus catheter, resistance was encountered.Pressure was applied to withdraw the device, and upon removal, it was noted that the radiopaque marker and distal tip had sheared off.The location was initially unclear, as the marker was not visible on fluoroscopy.During continued intervention, the radiopaque marker was observed in the left main coronary artery.Attempts were made to balloon distal and drag it out with a semi-inflated balloon; however, the final approach was to stent it into the vessel wall.The procedure was completed with an alternate device, and 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: 23043361
• Report Number: 2124215-2025-62959
• Device Sequence Number: 9871439
• Product Code: OBJ
• UDI-Device Identifier: 08714729960775
• UDI-Public: (01)08714729960775(17)270528(10)36624683
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 11/10/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939354080
• Device Catalogue Number: H74939354080
• Device Lot Number: 0036624683
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 10/17/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/28/2025
• 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