MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OPTICROSS 35; CATHETER, ULTRASOUND, INTRAVASCULAR

Model Number	H7493932800350
Medical Device Problem Codes	Detachment of Device or Device Component (2907); 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	11/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on 13dec2024.It was reported that the sheath crumbled and kink.The target lesion was located in the iliac artery.A opticross 35 vascular imaging catheter was used in deep vein thrombosis iliac procedure.However, when the catheter was prepared, it was noticed that the sheathing of the ivus device was separated, crumbled and kinked.The procedure was completed with a new one.No patient complications reported.However, returned device analysis revealed torn imaging window.
Additional Manufacturer Narrative
D2b pro code (product code): obj, itx.Device evaluated by mfr.: the device was returned for analysis.Visual and microscopic inspection observed kinks and torn in the imaging window assembly.The tip of the catheter was damaged.Based on the evidence, the reported allegation of kink catheter was confirmed, since the kink found during the visual test could have contributed to the reported issue.Additionally, the reported allegation of detachment of the sheath could not be confirmed, since the reported issue was not found during the visual test.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21114375
• Report Number: 2124215-2024-80226
• Device Sequence Number: 8760242
• Product Code: OBJ
• UDI-Device Identifier: 08714729984542
• UDI-Public: 08714729984542
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K200733
• 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
• Report Date (Section B): 01/09/2025

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: 09/06/2026
• Device Model Number: H7493932800350
• Device Catalogue Number: H7493932800350
• Device Lot Number: 0035231558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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