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

Model Number	H74939354080
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: premarket / 510(k) # k173820, k213593.Good faith effort attempts were made to try and retrieve additional details regarding the reported event.A supplemental report will be submitted if additional details become available.
Event or Problem Description
It was reported that a catheter issue occurred.An opticross 6 hd catheter was advanced over a non-boston scientific guidewire in the left anterior descending (lad) artery.Upon withdrawal, the wire appeared to have been captured by the rotation of the transducer and wrapped around the catheter.Both devices were removed.There were no patient complications and the patient fully recovered.

• 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: 23696448
• Report Number: 2124215-2025-87749
• Device Sequence Number: 10288326
• Product Code: OBJ
• UDI-Device Identifier: 08714729960775
• UDI-Public: (01)08714729960775(17)260610(10)34195645
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/02/2025

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 Expiration Date: 06/10/2026
• Device Model Number: H74939354080
• Device Catalogue Number: H74939354080
• Device Lot Number: 0034195645
• 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: 11/10/2025
• Initial Report FDA Received Date: 12/02/2025
• Date Device Manufactured: 06/10/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BMW GUIDEWIRE - ABBOTT
• Patient Sex: Unknown