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

Model Number	36705
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle was difficult to extend.A leveen needle electrode 2.0/17/15 was selected for use in a radiofrequency ablation procedure, to treat the liver.During the procedure, a needle was inserted and attempted to deploy close to the lesion.However, the handle was too tight to be used, even though it was tried again.The procedure was completed with another of the same device.The patient was in stable condition and no complications occurred.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned with its respective radio frequency ablation electrode cable, and no damages were observed.Functional inspection was performed, and the handle was extended and retracted, and the needle/tines could be activated without any problems.
Event or Problem Description
It was reported that the needle was difficult to extend.A leveen needle electrode 2.0/17/15 was selected for use in a radiofrequency ablation procedure, to treat the liver.During the procedure, a needle was inserted and attempted to deploy close to the lesion.However, the handle was too tight to be used, even though it was tried again.The procedure was completed with another of the same device.The patient was in stable condition and no complications occurred.

• Brand Name: LEVEEN SUPERSLIM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15195391
• Report Number: 2124215-2022-29695
• Device Sequence Number: 17636662
• Product Code: GEI
• UDI-Device Identifier: 08714729441694
• UDI-Public: 08714729441694
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K113090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2023

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: 11/17/2024
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0028409814
• 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: 07/18/2022
• Supplement Date Received by Manufacturer: 01/09/2023
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 01/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Sex: Female