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	09/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that the tines were difficult to deploy.A leveen needle electrode was selected for use in a radio frequency ablation procedure of the liver.When the needle was inserter into the lesion, the tines did not fully expand.A different device, same model, was used to complete the procedure.There were no patient complications.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.
Event or Problem Description
It was reported that the tines were difficult to deploy.A leveen needle electrode was selected for use in a radio frequency ablation procedure of the liver.When the needle was inserter into the lesion, the tines did not fully expand.A different device, same model, was used to complete the procedure.There were no patient complications.It was further reported the patient was stable after treatment was completed.
Event or Problem Description
It was reported that the tines were difficult to deploy.A leveen needle electrode was selected for use in a radio frequency ablation procedure of the liver.When the needle was inserter into the lesion, the tines did not fully expand.A different device, same model, was used to complete the procedure.There were no patient complications.It was further reported the patient was stable after treatment was completed.
Additional Manufacturer Narrative
E1 - initial reporter facility name: (b)(6) hospital.Device evaluated by manufacturer: during product analysis, it was observed that there were no visual damages on the electrode and the tines, moreover, during functional evaluation, the device extended and retracted the tines without resistance.Therefore, the reported complaint related to "needle/tines difficult to extend" was not confirmed.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12644474
• Report Number: 2134265-2021-12899
• Device Sequence Number: 16500824
• Product Code: GEI
• UDI-Device Identifier: 08714729441694
• UDI-Public: 08714729441694
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 11/15/2021

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: 12/21/2023
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0026552839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/27/2021
• Supplement Date Received by Manufacturer: 10/08/2021; 11/03/2021
• Initial Report FDA Received Date: 10/17/2021
• Supplement Report FDA Received Date: 10/28/2021; 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 60 KG