MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS?; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	H749518130
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b: pro code (product code) - itx, obj.
Event or Problem Description
It was reported that a catheter issue occurred.The 90% stenosed target lesion was located in a non-tortuous and calcified obtuse marginal (om) artery.Atherectomy was performed with a 1.5mm burr.An opticross imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion over a non-boston scientific (non-bsc) wire.Ivus showed that the calcium had been sufficiently modified, and after a successful pullback, the physician attempted to remove the catheter over the wire.However, the catheter could not be withdrawn, and the wire could not be advanced further down the vessel.It appeared that the catheter had completely grabbed onto the wire and wrapped around it.Everything had to be removed as one unit.The vessel was successfully rewired, and the procedure was completed.There were no patient complications.

• Brand Name: OPTICROSS?
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• 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: 22320749
• Report Number: 2124215-2025-41186
• Device Sequence Number: 8819554
• Product Code: ITX
• UDI-Device Identifier: 00191506035396
• UDI-Public: (01)00191506035396(17)250707(10)34380664
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K213593
• 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): 06/24/2025

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: 07/07/2025
• Device Model Number: H749518130
• Device Catalogue Number: H749518130
• Device Lot Number: 0034380664
• 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: 06/03/2025
• Initial Report FDA Received Date: 06/24/2025
• Date Device Manufactured: 07/07/2024
• 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: 0.014 BMW ELITE GUIDEWIRE.
• Patient Sex: Unknown