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

Model Number	H74939354080
Medical Device Problem Codes	Entrapment of Device (1212); Mechanical Problem (1384); Nonstandard Device (1420); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The opticross 6 hd imaging catheter was advanced for ultrasound examination of the moderately tortuous and moderately calcified target lesion.During the procedure, the catheter rotation locked up.The catheter became entangled with, and wrapped around, the non-boston scientific guidewire.The catheter and wire had to be removed together.The procedure was completed with an alternate device.There were no patient complications.
Additional Manufacturer Narrative
G4 premarket / 510(k): k173820, k213593.
Additional Manufacturer Narrative
G4 premarket / 510(k): k173820, k213593.The device was returned for analysis.Visual and microscopic inspection revealed the sheath was kinked, the imaging core was damaged, and there were ripples in the imaging window.Microscopic inspection revealed guidewire exit port and tip damage.The catheter was properly recognized by the imaging system when plugged into the motor drive unit, and no connection issues or errors were detected during its testing.The auto pullback could not be performed due to the device condition.
Event or Problem Description
It was reported that a catheter issue occurred.The opticross 6 hd imaging catheter was advanced for ultrasound examination of the moderately tortuous and moderately calcified target lesion.During the procedure, the catheter rotation locked up.The catheter became entangled with, and wrapped around, the non-boston scientific guidewire.The catheter and wire had to be removed together.The procedure was completed with an alternate device.There were no patient complications.

• 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: 23197051
• Report Number: 2124215-2025-69607
• Device Sequence Number: 9730139
• Product Code: OBJ
• UDI-Device Identifier: 08714729960775
• UDI-Public: (01)08714729960775(17)270528(10)36624684
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/20/2025

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: 0036624684
• 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: 09/16/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 11/20/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO RUNTHROUGH 0.014 GUIDEWIRE; TERUMO RUNTHROUGH 0.014 GUIDEWIRE
• Patient Sex: Unknown