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

Model Number	36723
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event estimated using first day of procedure month: (b)(6) 2024.
Event or Problem Description
It was reported that insufficient roll off occurred.In (b)(6) 2024, the patient underwent a hepatic radio frequency ablation (rfa) procedure with an rf3000 generator and a 17g, 5cm x 15cm rf leveen needle.The lesion measured about 25mm.Ablation was performed with two heat-up times at 200w for 15 minutes without reaching roll-off.No patient complications were reported.Post rfa procedure, in (b)(6) 2024, magnetic resonance imaging (mri) was performed, which concluded that the treatment had been successful even though the lesion had increased in size and no post-therapeutic scarring was visible.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20026016
• Report Number: 2124215-2024-51890
• Device Sequence Number: 12957896
• Product Code: GEI
• UDI-Device Identifier: 08714729454915
• UDI-Public: 08714729454915
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140502
• 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
• Report Date (Section B): 08/20/2024

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: 36723
• Device Catalogue Number: 36723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2024
• Initial Report FDA Received Date: 08/22/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown