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

Model Number	44021
Medical Device Problem Codes	Nonstandard Device (1420); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the catheter tip detached.An opticross 18 was selected for ultrasound examination of the target lesion.During removal of the catheter, the tip tore off.The physician needed to perform surgery in order to remove the tip.The detached portion of the catheter was able to be successfully removed, and the patient was able to fully recover.
Event or Problem Description
It was reported that the catheter tip detached.An opticross 18 was selected for ultrasound examination of the target lesion.During removal of the catheter, the tip tore off.The physician needed to perform surgery in order to remove the tip.The detached portion of the catheter was able to be successfully removed, and the patient was able to fully recover.
Additional Manufacturer Narrative
The returned product consisted of the opticross imaging catheter.An inspection of the media attached to the complaint shows the portion of the tip that was detached from the catheter.A visual inspection of the actual device showed that the sheath and imaging window were kinked and bent.The tip was observed as detached.A microscopic inspection revealed that the tip was torn apart from the catheter.This investigation has been assigned an investigation conclusion code of adverse event related to procedure.Regarding the observed kinked sheath and bent imaging window, this can occur during the procedure due to advancement maneuvers.In this process, the friction between the following elements: the catheter, the hemostasis valve, the guide catheter, and the lesion, creates a force that opposes the movement of the catheter.If the pushing force from the user and the opposing force caused by the friction, are not parallel, the sheath and imaging window could bend or collapse into a kink.It is most probable that the forces leading to the kinks and bent were caused during the procedure.

• 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: 23995172
• Report Number: 2124215-2026-01067
• Device Sequence Number: 13389264
• Product Code: OBJ
• UDI-Device Identifier: 08714729904748
• UDI-Public: (01)08714729904748(17)270901(10)37343568
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 44021
• Device Catalogue Number: 44021
• Device Lot Number: 0037343568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown