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

Model Number	8668
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The 90% stenosed target lesion was located in the severely calcified vessel.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the device was fractured.The physician was able to retrieve the device by introducing a guide extension, pulling the device into the extension, and completely removing it from the patients body.The procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that a catheter issue occurred.The 90% stenosed target lesion was located in the severely calcified vessel.The opticross hd imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the device was fractured.The physician was able to retrieve the device by introducing a guide extension, pulling the device into the extension, and completely removing it from the patients body.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
The device was returned for analysis.Visual and microscope inspections revealed that the imaging window was detached and twisted 17 cm from the lap joint section, and the sheath was kinked.An imaging core windup with a broken driveshaft began 139.1 cm from the distal end of the connector shaft.Based on this evidence, the catheter damaged/defective as reported code is confirmed.The imaging window twisting during the visual test could have contributed to the catheter damaged/defective condition.The imaging core windup with a broken driveshaft and detached imaging window found could contribute to device malfunction during the procedure; however, the kink found during the impedance test could not have contributed to the catheter damaged/defective condition.

• 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: 19418131
• Report Number: 2124215-2024-31426
• Device Sequence Number: 21019510
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

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: 08/07/2024
• Device Model Number: 8668
• Device Catalogue Number: 8668
• Device Lot Number: 0032176429
• 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: 05/08/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 05/29/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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
• Patient Sex: Unknown