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	11/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle was deformed.The target lesion was located in the right inferior lung.A 3.0/17/15 leveen superslim was selected for use.During the procedure, after local anesthesia, the device was found to be deformed and curved when taken out of the patient.A new ablation needle was used to complete the procedure.There were no patient complications, and the patient was stable post procedure.
Additional Manufacturer Narrative
Initial reporter address 1: (b)(6).
Event or Problem Description
It was reported that the needle was deformed.The target lesion was located in the right inferior lung.A 3.0/17/15 leveen superslim was selected for use.During the procedure, after local anesthesia, the device was found to be deformed and curved when taken out of the patient.A new ablation needle was used to complete the procedure.There were no patient complications, and the patient was stable post procedure.
Additional Manufacturer Narrative
E1: initial reporter address 1: (b)(6).Device evaluated by mfr: the electrode device was returned with the rfa electrode cable; nevertheless, media was provided, and it was observed that the device was bent.Visual inspection revealed no damages at the handle device and it was observed that the needle was bent.Functional inspection was performed by extending and retracting the handle, and the needle/tines were activated without any problems.

• 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: 18380473
• Report Number: 2124215-2023-72492
• Device Sequence Number: 7766955
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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: 07/23/2026
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0032074667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/06/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/24/2023
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 60 KG