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

Model Number	36705
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the electrode was bent.A 3.0cm x 15cm leveen superslim needle electrode was selected for use in a radio frequency ablation procedure in the liver.During the procedure, the liver was hard, and the device bent during the puncture.The device did not reach the tumor.After that, an attempt was made to continue the procedure with a different size, but the patient's condition was not good, so the procedure was abandoned for the day.Re-treatment was scheduled for the following week.No patient complications were reported.
Event or Problem Description
It was reported that the electrode was bent.A 3.0cm x 15cm leveen superslim needle electrode was selected for use in a radio frequency ablation procedure in the liver.During the procedure, the liver was hard, and the device bent during the puncture.The device did not reach the tumor.After that, an attempt was made to continue the procedure with a different size, but the patient's condition was not good, so the procedure was abandoned for the day.Re-treatment was scheduled for the following week.No patient complications were reported.It was further reported that the patient's condition was not good due to their blood pressure rising.The physician does not believe the device caused or contributed to the blood pressure increase.
Additional Manufacturer Narrative
Device eval by manufacturer: the electrode was returned for analysis.No damages were observed at the handle.However, it was observed that the tines were bent.Additionally, the needle was completely detached at the distal section, leaving the tines exposed.The handle could not extend and retract properly due to the needle being completely detached and the tines exposed.

• 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: 19948782
• Report Number: 2124215-2024-49023
• Device Sequence Number: 20733432
• Product Code: GEI
• UDI-Device Identifier: 08714729441717
• UDI-Public: 08714729441717
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113092
• 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): 09/05/2024

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 Expiration Date: 03/05/2026
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0031171527
• 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: 07/18/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2023
• 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 Sex: Unknown