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

Model Number	H7493932800350
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	03/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D2b - pro code (product code): obj, itx.
Event or Problem Description
It was reported that material twist occurred.An opticross 35 was selected for use in a venogram.During preparation, the catheter was attached to the sled.However, when the imaging was turned on for a test, the entire catheter uncoiled.The procedure was completed with a new catheter.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that material twist occurred.An opticross 35 was selected for use in a venogram.During preparation, the catheter was attached to the sled.However, when the imaging was turned on for a test, the entire catheter uncoiled.The procedure was completed with a new catheter.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
D2b - pro code (product code): obj, itx.H6 - device codes: updated.The device was not returned for evaluation.However, an analysis was concluded based on the received photo of the complaint device.The media attached to the parent record shows the imaging core coiled over the telescope.Additionally, the telescope was detached from the y manifold.No other issues were identified with the device.

• 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: 21857710
• Report Number: 2124215-2025-23511
• Device Sequence Number: 4709187
• Product Code: OBJ
• UDI-Device Identifier: 08714729984542
• UDI-Public: (01)08714729984542(17)261113(10)35678170
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Followup
• Report Date (Section B): 05/23/2025

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 Model Number: H7493932800350
• Device Catalogue Number: H7493932800350
• Device Lot Number: 0035678170
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2025
• Supplement Date Received by Manufacturer: 04/29/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/23/2025
• Date Device Manufactured: 11/13/2024
• 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