MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OptiCross 35; catheter, ultrasound, intravascular

Model Number	H7493932800350
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976); 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	04/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a catheter issue occurred.The opticross 35 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the ivus catheter became twisted and kinked while progressing forward with the motor drive unit turned on.The physician was able to remove the device.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 inspection showed kinks in the telescope and imaging assemblies.Microscopic inspection showed a bend in the imaging window assembly.Media provided by the customer does not show evidence of the reported issue.
Event or Problem Description
It was reported that a catheter issue occurred.The opticross 35 imaging catheter was advanced for intravascular ultrasound (ivus) examination of the target lesion.During the procedure, the ivus catheter became twisted and kinked while progressing forward with the motor drive unit turned on.The physician was able to remove the device.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: OptiCross 35
• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; +1(952)930-6396
• MDR Report Key: 19176849
• Report Number: 2124215-2024-24877
• Device Sequence Number: 6415240
• Product Code: OBJ
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K200733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2026

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: 07/12/2025
• Device Model Number: H7493932800350
• Device Catalogue Number: H7493932800350
• Device Lot Number: 0032488453
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/27/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 06/19/2024; Not provided
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 07/08/2024; 09/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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