MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 18; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	44021
Medical Device Problem Codes	Nonstandard Device (1420); Connection Problem (2900); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Reassessed as reportable based upon device analysis completed 10dec2025.It was reported that the catheter was not recognized and tip was damaged.An opticross 18 was selected for use.The device was reported broken as the system was unable to read the catheter data and the tip was not linear.No patient complications were reported.However, analysis revealed ripples in the imaging window.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The media provided shows the imaging window kinked.Visual and microscopic inspection and functional testing revealed the following: the sheath and imaging window were observed kinked.There were ripples found in the imaging window.Event date populated as the first day of the month of the aware date as an exact event date was not provided.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The media provided shows the imaging window kinked.Visual and microscopic inspection and functional testing revealed the following: the sheath and imaging window were observed kinked.There were ripples found in the imaging window.
Event or Problem Description
Reassessed as reportable based upon device analysis completed 10dec2025.It was reported that the catheter was not recognized and tip was damaged.An opticross 18 was selected for use.The device was reported broken as the system was unable to read the catheter data and the tip was not linear.The procedure was completed with an equivalent device.No patient complications were reported.However, analysis revealed ripples in the imaging window.

• Brand Name: OPTICROSS 18
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23878468
• Report Number: 2124215-2025-92653
• Device Sequence Number: 11929996
• Product Code: OBJ
• UDI-Device Identifier: 08714729904748
• UDI-Public: (01)08714729904748(17)270110(10)35604125
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K160514
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2026

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: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0035604125
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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
• Patient Sex: Unknown