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

Model Number	36723
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that insufficient roll off occurred.A 5.0/13/15 leveen standard rf electrode was selected for use in a pulmonary radio frequency ablation procedure.There was difficulty during placement, and no impedance.Patch was changed two times, but this did not resolve the issue.The electrode was exchanged, which did resolve the issue.Less than five minutes of time was wasted.No patient complications were reported.
Event or Problem Description
It was reported that insufficient roll off occurred.A 5.0/13/15 leveen standard rf electrode was selected for use in a pulmonary radio frequency ablation procedure.There was difficulty during placement, and no impedance.Patch was changed two times, but this did not resolve the issue.The electrode was exchanged, which did resolve the issue.Less than five minutes of time was wasted.No patient complications were reported.It was further reported that roll off was achieved with a new electrode, and the patient had a good outcome post procedure.

• Brand Name: LEVEEN STANDARD
• 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: 17020686
• Report Number: 2124215-2023-26722
• Device Sequence Number: 20418934
• Product Code: GEI
• UDI-Device Identifier: 08714729454915
• UDI-Public: 08714729454915
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140502
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2023

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: 12/14/2025
• Device Model Number: 36723
• Device Catalogue Number: 36723
• Device Lot Number: 0030718017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown