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

Model Number	M001262280
Medical Device Problem Codes	Failure to Unfold or Unwrap (1669); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the array was difficult to extend.A 2.0cm x 15cm leveen superslim needle electrode was selected for use in the radiofrequency ablation of a 3cm liver tumor.After positioning and inserting the needle electrode into the lesion, the array could not be fully opened and slid.After several attempts, the same situation occurred.After removing the needle electrode, it was found that the array was deformed.The procedure was completed with this device.No patient complications were reported, and the patient was in stable condition following the procedure.
Event or Problem Description
It was reported that the array was difficult to extend.A 2.0cm x 15cm leveen superslim needle electrode was selected for use in the radiofrequency ablation of a 3cm liver tumor.After positioning and inserting the needle electrode into the lesion, the array could not be fully opened and slid.After several attempts, the same situation occurred.After removing the needle electrode, it was found that the array was deformed.The procedure was completed with this device.No patient complications were reported, and the patient was in stable condition following the procedure.
Additional Manufacturer Narrative
D4: model number, lot number, catalog number, expiration date, and unique identifier (udi) # updated based on additional information received.Device eval by manufacturer: the device was returned to boston scientific for analysis.It was possible to observe that the needles were bent.Functional testing was performed; the handle was extended and retracted, and the needle/tines could be activated without any issue.The reported issue of a deformed array was confirmed; however, the reported difficulty extending the array could not be confirmed.

• Brand Name: LEVEEN SUPERSLIM
• 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: 20798759
• Report Number: 2124215-2024-75031
• Device Sequence Number: 12453513
• Product Code: GEI
• UDI-Device Identifier: 08714729441717
• UDI-Public: 08714729441717
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

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 Model Number: M001262280
• Device Catalogue Number: M001262280
• Device Lot Number: 0033708197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/26/2024
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 70 KG