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

Model Number	M001262280
Medical Device Problem Codes	Retraction Problem (1536); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tines of the needle were bent/tangled and difficult to retract.This 3.0/17/15 leveen? superslim needle electrode was selected for use in a liver computed tomography (ct) guided ablation therapy procedure for liver cancer.During the procedure, the first time the needle was withdrawn, it was withdrawn smoothly.The second time the needle was withdrawn, the shape of the needle was distorted, and the needle could not be withdrawn smoothly.After several attempts of position adjustment, when the radiofrequency needle was removed, it was observed that the needle tines were entangled with each other.The procedure was completed with this device and the patient condition following the procedure was stable.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this 3.0/17/15 leveen? superslim needle electrode was visually inspected, revealing that the needles were kinked.A functional test was performed, and the needles could be extended and retracted normally.The clinical observation of needles kinked was confirmed, and the clinical observation of difficult to retract was not confirmed via analysis.
Event or Problem Description
It was reported that the tines of the needle were bent/tangled and difficult to retract.This 3.0/17/15 leveen? superslim needle electrode was selected for use in a liver computed tomography (ct) guided ablation therapy procedure for liver cancer.During the procedure, the first time the needle was withdrawn, it was withdrawn smoothly.The second time the needle was withdrawn, the shape of the needle was distorted, and the needle could not be withdrawn smoothly.After several attempts of position adjustment, when the radiofrequency needle was removed, it was observed that the needle tines were entangled with each other.The procedure was completed with this device and the patient condition following the procedure was stable.
Event or Problem Description
It was reported that the tines of the needle were bent/tangled and difficult to retract.This 3.0/17/15 leveen? superslim needle electrode was selected for use in a liver computed tomography (ct) guided ablation therapy procedure for liver cancer.During the procedure, the first time the needle was withdrawn, it was withdrawn smoothly.The second time the needle was withdrawn, the shape of the needle was distorted, and the needle could not be withdrawn smoothly.After several attempts of position adjustment, when the radiofrequency needle was removed, it was observed that the needle tines were entangled with each other.The procedure was completed with this device and the patient condition following the procedure was stable.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this 3.0/17/15 leveen? superslim needle electrode was visually inspected, revealing that the needles were kinked.A functional test was performed, and the needles could be extended and retracted normally.The clinical observation of needles kinked was confirmed, and the clinical observation of difficult to retract was not confirmed via analysis.

• 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: 22548343
• Report Number: 2124215-2025-42436
• Device Sequence Number: 8727110
• Product Code: GEI
• UDI-Device Identifier: 08714729441717
• UDI-Public: (01)08714729441717(17)270326(10)33706910
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2025

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: 0033706910
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 08/14/2025; 10/10/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 09/09/2025; 10/23/2025
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 61 KG