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

Model Number	36705
Medical Device Problem Codes	Defective Device (2588); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle was deformed and in a deployed state upon unpacking.A 3.0/17/15 leveen superslim needle electrode was selected for use in the radiofrequency ablation of lung tumors.During preparation, upon unpacking the device, it was noted that the needle was deformed and was in a deployed state.The procedure was completed with another of the same device.No patient complications were reported, and the patient was in stable condition following the procedure.
Additional Manufacturer Narrative
Device eval by manufacturer: the leveen superslim needle electrode was returned for analysis.No damage was observed on the handle; however, it was observed that the needles were bent.The handle was extended and retracted, and the needle/tines could be activated without any issues.An electrical evaluation was performed by measuring the continuity, and the electrode was able to conduct current indicating proper connectivity.
Event or Problem Description
It was reported that the needle was deformed and in a deployed state upon unpacking.A 3.0/17/15 leveen superslim needle electrode was selected for use in the radiofrequency ablation of lung tumors.During preparation, upon unpacking the device, it was noted that the needle was deformed and was in a deployed state.The procedure was completed with another of the same device.No patient complications were reported, and the patient was in stable condition 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: 17886054
• Report Number: 2124215-2023-55326
• Device Sequence Number: 12504068
• Product Code: GEI
• UDI-Device Identifier: 08714729441717
• UDI-Public: 08714729441717
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 11/28/2023

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: 05/21/2026
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0031666423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/15/2023
• Supplement Date Received by Manufacturer: 10/31/2023
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 11/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 75 KG