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

Model Number	8655
Medical Device Problem Codes	Entrapment of Device (1212); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the guidewire became entangled with the catheter.An opticross imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the guidewire within the catheter sheath twisted and externalized outside the catheter.The device was removed, and another opticross imaging catheter was advanced.The second opticross imaging catheter encountered the same issue with the guidewire.A third imaging catheter was then used to successfully complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
The returned product consisted of the opticross imaging catheter.A visual inspection of the device revealed no damages or defects, however a microscopic analysis revealed that the guidewire exit port was damaged.A test guidewire was used for functional testing, and there was no resistance in tracking the guidewire into the catheter.Regarding the damaged exit port, it occurs due to friction between the edges of the exit port and the guidewire, this friction could be encountered during the advancement of the device since the anatomy characteristics and the maneuvers by the user could lead to an excessive friction that deforms the material.Since no deviations were found in the device history record review, it is most probable that the issue occurred during the procedure.Based on the evidence, this investigation was assigned a conclusion code of adverse event related to procedure.
Event or Problem Description
It was reported that the guidewire became entangled with the catheter.An opticross imaging catheter was advanced for ultrasound examination of the target lesion.During the procedure, the guidewire within the catheter sheath twisted and externalized outside the catheter.The device was removed, and another opticross imaging catheter was advanced.The second opticross imaging catheter encountered the same issue with the guidewire.A third imaging catheter was then used to successfully complete the procedure.There were no patient complications.

• Brand Name: OPTICROSS
• 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: shields rachel ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19995946
• Report Number: 2124215-2024-50884
• Device Sequence Number: 20978898
• Product Code: OBJ
• UDI-Device Identifier: 08714729841531
• UDI-Public: 08714729841531
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 10/25/2024

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: 04/06/2025
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0033771084
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 10/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2024
• 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