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

Model Number	H74939352040
Medical Device Problem Codes	Off-Label Use (1494); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that catheter issue occurred.The 90% stenosed target lesion was located in the anterior tibial artery.The opticross imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the intravascular ultrasound catheter twisted upon itself.However, the device was successfully retrieved.The patient was admitted to the hospital beyond the standard of care.
Additional Manufacturer Narrative
D4: lot number: updated.G4: premarket / 510(k) #: k173284, k213593.
Event or Problem Description
It was reported that catheter issue occurred.The 90% stenosed target lesion was located in the anterior tibial artery.The opticross imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the intravascular ultrasound catheter twisted upon itself.However, the device was successfully retrieved.The patient was admitted to the hospital beyond the standard of care.
Additional Manufacturer Narrative
The device was returned for analysis.Visual and microscope inspections revealed that the sheath was kinked and detached, the drive shaft and coaxial cable were broken, the imaging window and drive cable were twisted, and the imaging window was torn.Microscope inspection also revealed that the guidewire exit port was lifted, but the distal section of the tip was in good condition.G4: premarket / 510(k) # - k173284, k213593.
Event or Problem Description
It was reported that catheter issue occurred.The 90% stenosed target lesion was located in the anterior tibial artery.The opticross imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, the intravascular ultrasound catheter twisted upon itself.However, the device was successfully retrieved.The patient was admitted to the hospital beyond the standard of care.

• 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: 21353186
• Report Number: 2124215-2025-05695
• Device Sequence Number: 15723122
• Product Code: OBJ
• UDI-Device Identifier: 08714729960737
• UDI-Public: (01)08714729960737(17)251104(10)35211509
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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,Followup
• Report Date (Section B): 05/02/2025

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: 11/04/2025
• Device Model Number: H74939352040
• Device Catalogue Number: H74939352040
• Device Lot Number: 0035211509
• 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: 01/13/2025
• Supplement Date Received by Manufacturer: 02/13/2025; 04/08/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/10/2025; 05/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male