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

Model Number	8668
Medical Device Problem Codes	Material Integrity Problem (2978); Material Twisted/Bent (2981); 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
Event or Problem Description
It was reported that catheter issue occurred.The opticross hd imaging catheter was selected for ultrasound examination of the target lesion.During the procedure the catheter unraveled itself and the tip was damage.The procedure was completed using an alternate device.No patient complications were reported.
Additional Manufacturer Narrative
The device was returned for analysis.Visual and microscopic inspection revealed the imaging window was twisted and torn, and the imaging core was wound up with broken driveshaft at the end.The guidewire exit port was lifted, but the distal section of the tip was in good condition.The reported events of material twisted and damage tip were confirmed.
Event or Problem Description
It was reported that catheter issue occurred.The opticross hd imaging catheter was selected for ultrasound examination of the target lesion.During the procedure the catheter unraveled itself and the tip was damage.The procedure was completed using an alternate device.No patient complications were reported.

• 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: 19960679
• Report Number: 2124215-2024-49730
• Device Sequence Number: 7136919
• Product Code: OBJ
• UDI-Device Identifier: 08714729960737
• UDI-Public: 08714729960737
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2024

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: 05/24/2025
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0034105217
• 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: 07/22/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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