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

Model Number	H74939240035130
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hole in the catheter was noted.A 135cm rubicon 35 catheter was selected for use.During preparation, while loading the catheter on wire and advancing it toward the sheath, a hole was noticed in the catheter.The catheter was never inside the sheath or patient, so the physician pulled back off the wire.The procedure was completed with another of the same device and no patient complications were reported.
Additional Manufacturer Narrative
This report is being filed to correct the model number and unique identifier (udi) # in response to an fda request.
Event or Problem Description
It was reported that a hole in the catheter was noted.A 135cm rubicon 35 catheter was selected for use.During preparation, while loading the catheter on wire and advancing it toward the sheath, a hole was noticed in the catheter.The catheter was never inside the sheath or patient, so the physician pulled back off the wire.The procedure was completed with another of the same device and no patient complications were reported.

• 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: 18238165
• Report Number: 2124215-2023-63762
• Device Sequence Number: 16937946
• Product Code: DQY
• UDI-Device Identifier: 08714729832072
• UDI-Public: (01)08714729832072(17)260626(10)31898944
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 07/03/2024

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: 06/26/2026
• Device Model Number: H74939240035130
• Device Catalogue Number: 39540
• Device Lot Number: 0031898944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2023
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2023
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Race: White