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

Model Number	36721
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Defective Device (2588); Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the array did not deploy properly, and insufficient roll off occurred.A 4.0/14/15 leveen standard probe was selected for use in a radio frequency ablation procedure in a metastatic lung tumor.During the procedure, the handle of the needle was completely loose, and the peak of the needle slipped out completely with minimal forward movement.The needle was stuck in the tumor, and after deployment of the array, the white plastic end slipped back, so the needle was not completely open.Treatment was performed with two cycles, but there was no roll off.The needle was not exchanged since there were no additional needles available.No patient complications were reported.
Event or Problem Description
It was reported that the array did not deploy properly, and insufficient roll off occurred.A 4.0/14/15 leveen standard probe was selected for use in a radio frequency ablation procedure in a metastatic lung tumor.During the procedure, the handle of the needle was completely loose, and the peak of the needle slipped out completely with minimal forward movement.The needle was stuck in the tumor, and after deployment of the array, the white plastic end slipped back, so the needle was not completely open.Treatment was performed with two cycles, but there was no roll off.The needle was not exchanged since there were no additional needles available.No patient complications were reported.
Additional Manufacturer Narrative
This supplemental report was not able to be submitted on-time by boston scientific because of delayed acknowledgements from fda for the initial report.An fda system issue resulted in the delayed acknowledgements.This report will not be considered late, because it was the result of an fda system issue.Device eval by manufacturer: the device was returned with its respective radiofrequency ablation electrode cable, and no damages were observed.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.A resistance test was performed, and the device was within specification.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16515745
• Report Number: 2124215-2023-11174
• Device Sequence Number: 20365701
• Product Code: GEI
• UDI-Device Identifier: 08714729295594
• UDI-Public: 08714729295594
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K140500
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2023

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: 10/16/2025
• Device Model Number: 36721
• Device Catalogue Number: 36721
• Device Lot Number: 0030360901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Supplement Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 03/09/2023
• Supplement Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male