MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RUBICON 18; CATHETER, PERCUTANEOUS

Model Number	39540
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the catheter tip detached.The target lesion was located in the mildly tortuous popliteal and superficial femoral artery.When a pedal access was obtained a 90cm rubicon 18 catheter-guide was inserted.During the procedure, when the patient moved his feet slightly, the tip of the catheter got kinked and snapped in half.Fluoroscopy was reviewed to ensure the detached tip did not obstruct the vessel.After confirming that the vessel was not obstructed, the physician proceeded with the procedure.No patient complications were reported.
Event or Problem Description
It was reported that the catheter tip detached, the target lesion was located in the mildly tortuous popliteal and superficial femoral artery.When a pedal access was obtained a 90cm rubicon 18 catheter-guide was inserted.During the procedure, when the patient moved his feet slightly, the tip of the catheter got kinked and snapped in half.Fluoroscopy was reviewed to ensure the detached tip did not obstruct the vessel.After confirming that the vessel was not obstructed, the physician proceeded with the procedure.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.The device was visually and microscopically inspected for damage.The devices shaft showed damage in the form of bends and kinks located on the distal end of shaft.A separation located approximately 3cm from the tip.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The device was confirmed for bends and a separation of the shaft.

• Brand Name: RUBICON 18
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17731543
• Report Number: 2124215-2023-47905
• Device Sequence Number: 6093306
• Product Code: DQY
• UDI-Device Identifier: 08714729829232
• UDI-Public: 08714729829232
• 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): 11/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/24/2026
• Device Model Number: 39540
• Device Catalogue Number: 39540
• Device Lot Number: 0030923676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 10/24/2023
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Race: White