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

Model Number	8668
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	04/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During insertion, difficulty in tracking and retracting on the non-boston scientific guidewire was encountered.The ivus catheter could not be removed from the guidewire.The ivus catheter was removed along with the guidewire through the guide catheter, and the procedure was completed with another of the same device.There were no patient complications reported.
Event or Problem Description
It was reported that a catheter issue occurred.The stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During insertion, difficulty in tracking and retracting on the non-boston scientific guidewire was encountered.The ivus catheter could not be removed from the guidewire.The ivus catheter was removed along with the guidewire through the guide catheter, and the procedure was completed with another of the same device.There were no patient complications reported.
Additional Manufacturer Narrative
The device was returned for analysis.Visual and microscope inspections revealed that a kink was observed in the telescope assembly, the guidewire exit port was torn, and a guidewire was stuck.The media returned by the customer was inspected and did not show the device or any evidence of the reported issue.

• Brand Name: OPTICROSS HD
• 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: 19396281
• Report Number: 2124215-2024-30023
• Device Sequence Number: 18085727
• Product Code: OBJ
• UDI-Device Identifier: 08714729960737
• UDI-Public: 08714729960737
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: 11/20/2024
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0032881818
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 11/06/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/21/2023
• Is the Device Labeled for Single Use? (Y/N): No
• 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: HI-TORQUE BMW GUIDE; HI-TORQUE BMW GUIDE
• Patient Sex: Unknown