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

Model Number	36719
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that insufficient roll-off occurred.A 3.5cm x 25cm leveen standard needle electrode was selected for use in a radio frequency ablation procedure.The device was used in the abdomen.The impendance did not increase during ablation, and it was thought that it was possibly inside the blood vessels.However, it was then confirmed with echocardiography that it was not inside the blood vessels.Since the device could not be used, the device was exchanged.Another size was used to successfully complete the procedure.No patient complications were reported.

• 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: 18968582
• Report Number: 2124215-2024-17559
• Device Sequence Number: 20372169
• Product Code: GEI
• UDI-Device Identifier: 08714729349594
• UDI-Public: 08714729349594
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140501
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2024

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: 10/13/2024
• Device Model Number: 36719
• Device Catalogue Number: 36719
• Device Lot Number: 0028202573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/02/2024
• Initial Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2021
• 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: Unknown