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

Model Number	8655
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia (1942)
Date of Event	03/17/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).
Event or Problem Description
It was reported that patient death had occurred.An opticross imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the catheter became tangled with stent struts or the guidewire and was trapped.It took more than three hours to remove and complete the procedure.The patient passed away 1.5 hours later, probably due to ischemia during the procedure.
Event or Problem Description
It was reported that patient death had occurred.An opticross imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the catheter became tangled with stent struts or the guidewire and was trapped.It took more than three hours to remove and complete the procedure.The patient passed away 1.5 hours later, probably due to ischemia during the procedure.It was further reported that 5 stents were used in the procedure.The stent involved with the opticross entanglement was properly seated but was not post dilated.Another opticross was used after retrieving the tangled devices.An autopsy was not performed.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter address 1 - (b)(6).The device was returned for analysis.Visual and microscopic inspection revealed the sheath detached from the telescope section.The detached section of the sheath, including the imaging window and tip, were not returned for analysis.The driveshaft was found broken and cut with a windup and a section twisted.The device was returned with 2 non-boston scientific guidewires, one with added material.Microscope inspection revealed the drive cable was also cut.Media provided by the customer was inspected.Two pictures showed the drive cable (driveshaft) broken but were not clear enough to identify any other failures.One picture showed the drive cable with a section twisted.Another picture showed the distal section of the imaging window detached with a bend, but the picture is not clear enough to identify tip damage.Two pictures captured from a mobile phone were provided of still angiographic frames.The first still image showed the guide catheter in the aorta, outside the left main stem, the opticross catheter, and what appears to be a snare catheter.It also showed what appears to possibly be a kinked catheter right outside the left main stem.The second picture showed what seems to be the same still frame visible in the first picture and showed the opticross catheter inside the stent(s) in the lad.Only the frame of the stents is visible.The stent(s) seem to be underexpanded in the mid-distal part of the artery.
Event or Problem Description
It was reported that patient death had occurred.An opticross imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the catheter became tangled with stent struts or the guidewire and was trapped.It took more than three hours to remove and complete the procedure.The patient passed away 1.5 hours later, probably due to ischemia during the procedure.It was further reported that 5 stents were used in the procedure.The stent involved with the opticross entanglement was properly seated but was not post dilated.Another opticross was used after retrieving the tangled devices.An autopsy was not performed.

• Brand Name: OPTICROSS
• 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: 21653878
• Report Number: 2124215-2025-17036
• Device Sequence Number: 15785028
• Product Code: OBJ
• UDI-Device Identifier: 08714729841531
• UDI-Public: (01)08714729841531(17)251119(10)35313214
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/26/2025

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 Expiration Date: 11/19/2025
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0035313214
• 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: 03/17/2025
• Supplement Date Received by Manufacturer: 03/26/2025; 06/19/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/16/2025; 06/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• 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: Death
• Patient Sex: Female