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	12/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle was bent.A 2.0/17/15 leveen superslim was selected for use in a radiofrequency ablation procedure in the liver.During preparation, the needle was found bent.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient status was stable following the procedure.
Additional Manufacturer Narrative
E1: (b)(6).
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).E1: initial reporter address 1: (b)(6).E1: initial reporter phone: (b)(6).Investigation results: device technical analysis: upon receipt at our post market quality assurance laboratory, the rf probes with the electric cable were examined.Visual inspection revealed no damages in the needles.Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Risk review: a risk review performed for the leveen superslim confirmed that the event of needle/tines bent and bent/kinked are known events defined in the products risk management documentation.This event has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of device problem excluded.
Event or Problem Description
It was reported that the needle was bent.A 2.0/17/15 leveen superslim was selected for use in a radiofrequency ablation procedure in the liver.During preparation, the needle was found bent.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient status was stable following the procedure.

• 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: 24019377
• Report Number: 2124215-2026-01238
• Device Sequence Number: 13059278
• Product Code: GEI
• UDI-Device Identifier: 08714729441694
• UDI-Public: (01)08714729441694(17)280115(10)35636033
• 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): 04/01/2026

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: M001262260
• Device Catalogue Number: M001262260
• Device Lot Number: 0035636033
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 01/09/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2025
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 69 KG