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

Model Number	M001262260
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	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle was bent.Upon opening the package of this 2.0/17/15 leveen superslim needle electrode, the needle section was bent, and it was stuck when the needle came out.The procedure was completed with another of the same device.The patient condition following the procedure was stable.
Event or Problem Description
It was reported that the needle was bent.Upon opening the package of this 2.0/17/15 leveen superslim needle electrode, the needle section was bent, and it was stuck when the needle came out.The procedure was completed with another of the same device.The patient condition following the procedure was stable.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, analysis was performed on this 2.0/17/15 leveen superslim needle electrode.Visual inspection found that the needles were bent, and functional inspection found that the needles could be extended normally.A picture was provided with the event details, and it was possible to observe that the needles were bent, and the needles did not appear fully extended.The clinically observed needle/tines bent could be confirmed; however, the clinically observed needle/tines difficult to extend could not be confirmed, since the functional inspection passed.

• 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: 21394439
• Report Number: 2124215-2025-04169
• Device Sequence Number: 21019422
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: M001262260
• Device Catalogue Number: M001262260
• Device Lot Number: 0032643895
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 03/20/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 58 KG