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

Model Number	M001262260
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle was bent.A 2.0cm x 15cm leveen? superslim? needle electrode system was selected for use in a radio frequency ablation procedure to treat liver cancer.During the procedure inside the patient, it was noted that the needle was bent, resulting in frequent shutdown.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was in stable condition following the procedure.
Event or Problem Description
It was reported that the needle was bent.A 2.0cm x 15cm leveen? superslim? needle electrode system was selected for use in a radio frequency ablation procedure to treat liver cancer.During the procedure inside the patient, it was noted that the needle was bent, resulting in frequent shutdown.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient was in stable condition following the procedure.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis and upon visual inspection, it was possible to observe that the needles were bent, which confirms the reported event.

• 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: 23110688
• Report Number: 2124215-2025-66247
• Device Sequence Number: 21290159
• Product Code: GEI
• UDI-Device Identifier: 08714729441694
• UDI-Public: (01)08714729441694(17)260924(10)32498903
• 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): 11/17/2025

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 Expiration Date: 09/24/2026
• Device Model Number: M001262260
• Device Catalogue Number: M001262260
• Device Lot Number: 0032498903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2023
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 65 KG