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

Model Number	8655
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Visual and microscope inspections revealed that the imaging window was twisted, and the sheath was kinked and detached.Microscope inspection also revealed that the imaging core had wound up and the drive shaft was broken.
Event or Problem Description
Reportable based on device analysis completed on 22 oct 2024.It was reported that a catheter issue occurred.The stenosed target lesion was located in the right coronary artery.A non-boston scientific (non-bsc) 3.5 6f guide catheter was placed.And the opticross imaging catheter was advanced over a non-bsc guidewire for intravascular ultrasound (ivus) examination of the lesion.The catheter kinked while advancing into the lesion and the procedure was completed with another of the same device.No patient complications were reported, and the patient was stable following the procedure.However, device analysis revealed that the imaging window was twisted, and the sheath was kinked and detached.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20630717
• Report Number: 2124215-2024-69579
• Device Sequence Number: 7929335
• Product Code: OBJ
• UDI-Device Identifier: 08714729841531
• UDI-Public: 08714729841531
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Report Date (Section B): 11/07/2024

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: 04/19/2025
• Device Model Number: 8655
• Device Catalogue Number: 8655
• Device Lot Number: 0033864605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2024
• 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: LAUNCHER JR 3.5 6F GUIDE CATHETER.; TERUMO RUNTHROUGH GUIDEWIRE.
• Patient Sex: Male