MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 35; CATHETER, PERCUTANEOUS

Model Number	39540
Medical Device Problem Codes	Material Perforation (2205); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that shaft perforation occurred.The 100% stenosed target lesion was located in the tortuous and severely calcified proximal superficial femoral artery.A 135 cm rubicon 35 catheter guide was used in a lower extremity angiogram.During the procedure, the rubicon was used to navigate through a bypass.An aneurysm was located near the top of the bypass.While attempting to advance, both the non-boston scientific wire and rubicon were kinked at about 10 inches from the tip.It was noted that the wire had gone through the side of the rubicon, consequently caused a rip.The device was removed intact, and the procedure was completed using an alternate device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that shaft perforation occurred.The 100% stenosed target lesion was located in the tortuous and severely calcified proximal superficial femoral artery.A 135 cm rubicon 35 catheter guide was used in a lower extremity angiogram.During the procedure, the rubicon was used to navigate through a bypass.An aneurysm was located near the top of the bypass.While attempting to advance, both the non-boston scientific wire and rubicon were kinked at about 10 inches from the tip.It was noted that the wire had gone through the side of the rubicon, consequently caused a rip.The device was removed intact, and the procedure was completed using an alternate device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
The device was not received; however the media submitted with the complaint has been thoroughly examined and evaluated to reveal a shaft kink and hole located near the distal end of the rubicon.

• Brand Name: RUBICON 35
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 21805435
• Report Number: 2124215-2025-21563
• Device Sequence Number: 12614546
• Product Code: DQY
• UDI-Device Identifier: 08714729832072
• UDI-Public: (01)08714729832072(17)270827(10)34728801
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K122394
• 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): 05/12/2025

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: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0034728801
• 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: 03/14/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 05/12/2025
• Date Device Manufactured: 08/27/2024
• 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: Female