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

Model Number	H749518130
Medical Device Problem Codes	Poor Quality Image (1408); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b pro code (product code): obj.The device was returned for analysis.Visual inspection revealed the imaging window was kinked.Microscopic inspection revealed the imaging window had ripples, the imaging core was twisted, and the imaging window was perforated.The impedance test showed an electrical open at the proximal end of the catheter between 130-140 cm from the distal housing.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Event or Problem Description
Reportable based on device analysis completed on 3oct2025.It was reported that a catheter issue occurred.The opticross imaging catheter was advanced for ultrasound examination of the target lesion.During an image run, there was a snap sound followed by loss of the image.The procedure was completed with a new device.There were no patient complications.However, device analysis revealed the catheter was twisted and perforated.

• 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: 23356275
• Report Number: 2124215-2025-75509
• Device Sequence Number: 21050803
• Product Code: ITX
• UDI-Device Identifier: 00191506035396
• UDI-Public: (01)00191506035396(17)250707(10)34380664
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/22/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 10/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown