MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LEVEEN COACCESS; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	36700
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that insufficient roll off occurred.A 3.5/15/15 leveen coaccess was selected for a radio frequency ablation procedure to treat renal cell carcinoma.A 15 minute burn was performed ending at 180w per the protocol.The machine was restarted and burned again for another 15 minutes.No impedance was seen during both of these burns.In fact, it appeared as if the impedance was decreasing throughout the burn.All connections were checked and the cord felt warm as well as its connection to the needle.Once the machine reset at 15 minutes after the second burn, the physician wanted to scan to make sure a burn was created.Gas was seen on imaging so the physician thought a burn was created.The machine was started for a third burn at 180w.After 5 more minutes, and still no impedance, the needle was swapped out with another of the same device, keeping the original trocar.The burn was started again at 180w and within 7 minutes roll-off was reached.A final scan was completed, and the physician was satisfied with the burn.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.Visual inspection revealed no damages.The handle was extended and retracted, and the needle/tines could be activated without any problems.An electrical evaluation was performed by measuring the continuity, the electrode was able to conduct current indicating proper connectivity.The resistance test result was within specification.
Event or Problem Description
It was reported that insufficient roll off occurred.A 3.5/15/15 leveen coaccess was selected for a radio frequency ablation procedure to treat renal cell carcinoma.A 15 minute burn was performed ending at 180w per the protocol.The machine was restarted and burned again for another 15 minutes.No impedance was seen during both of these burns.In fact, it appeared as if the impedance was decreasing throughout the burn.All connections were checked and the cord felt warm as well as its connection to the needle.Once the machine reset at 15 minutes after the second burn, the physician wanted to scan to make sure a burn was created.Gas was seen on imaging so the physician thought a burn was created.The machine was started for a third burn at 180w.After 5 more minutes, and still no impedance, the needle was swapped out with another of the same device, keeping the original trocar.The burn was started again at 180w and within 7 minutes roll-off was reached.A final scan was completed, and the physician was satisfied with the burn.There were no patient complications.

• Brand Name: LEVEEN COACCESS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20097794
• Report Number: 2124215-2024-53625
• Device Sequence Number: 15563928
• Product Code: GEI
• UDI-Device Identifier: 08714729295617
• UDI-Public: 08714729295617
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K140505
• 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): 10/07/2024

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: 05/07/2026
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0031571555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 09/13/2024
• Initial Report FDA Received Date: 08/29/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown