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

Model Number	H74939354080
Medical Device Problem Codes	Entrapment of Device (1212); Failure to Advance (2524); Device-Device Incompatibility (2919); Material Integrity Problem (2978); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The patient was being treated for in-stent restenosis (isr).The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified in the left anterior descending artery (lad).An opticross 6 hd imaging catheter was selected for ultrasound examination of the target lesion.During the procedure, two wolverine balloons and two semi-compliant balloons were used to pre-dilate the lesion.Despite multiple attempts, the opticross catheter could not cross the lesion.After stent placement, the opticross again failed to cross.When the opticross reached the non-boston scientific (non-bsc) guide catheter, the non- bsc guidewire retracted into the proximal lad.Experiencing significant resistance and not wanting to exert further force on the opticross which had become bonded to the guidewire, the physician decided to remove the entire system.Once outside the patient, the guidewire was successfully removed from the opticross, and the guidewire was removed from the guide catheter.Minor damage was noted to the distal tip of the opticross and the area around the monorail port felt sharp to the touch.The procedure was completed using an alternative method.There were no patient complications.
Additional Manufacturer Narrative
G4: premarket/510(k) #: k173820, k213593.

• 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: 22183304
• Report Number: 2124215-2025-37249
• Device Sequence Number: 15600520
• Product Code: OBJ
• UDI-Device Identifier: 08714729960775
• UDI-Public: (01)08714729960775(17)270326(10)36155489
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 06/11/2025

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: 0036155489
• 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: 05/20/2025
• Initial Report FDA Received Date: 06/11/2025
• Date Device Manufactured: 03/26/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RUNTHROUGH GUIDEWIRE: TERUMO
• Patient Sex: Unknown