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

Model Number	M001262050
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle was difficult to retract from the patient.A leveen? standard radiofrequency ablation (rf) probe was selected for use to treat a case of hepatocellular carcinoma (hcc).The device was extend into the patient for treatment.The device was able to be retracted and positioned at this time.The ablation was completed, but when removal of the probe was attempted, the device was stuck.Eventually, the probe was able to be retracted and removed from the patient.There were no patient complications as a result of this event, and the patient fully recovered.

• Brand Name: LEVEEN? STANDARD
• 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: ricardo amaro castro ; 4100 hamline ave n; arden hills, MN 55112 ; 9529306396
• MDR Report Key: 24767739
• Report Number: 2124215-2026-17913
• Device Sequence Number: 21348138
• Product Code: GEI
• UDI-Device Identifier: 08714729300632
• UDI-Public: (01)08714729300632(17)281016(10)37733751
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140495
• 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): 05/26/2026

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: M001262050
• Device Catalogue Number: M001262050
• Device Lot Number: 0037733751
• 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: 03/05/2026
• Supplement Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 04/02/2026
• Supplement Report FDA Received Date: 05/26/2026
• Date Device Manufactured: 10/17/2025
• 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 Sex: Unknown