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

Model Number	36705
Medical Device Problem Code	Failure to Unfold or Unwrap (1669)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: the leveen superslim needle electrode was returned for analysis, and no damages were observed at the handle of the device.However, it was observed that the needle was bent.Functional testing was performed, and the handle extended and retracted; the needle/tines could be activated without any problems.The reported issue of the array not deploying properly could not be confirmed.
Event or Problem Description
It was reported that the array did not deploy properly.A 2.0cm x 15cm leveen superslim needle electrode was selected for use in a radiofrequency ablation procedure.During the procedure, a needle deployment failure occurred.When attempting to deploy the needle after the puncture, it did not open normally.The needle was removed.The needle size was changed to a 3.0cm x 15cm, and ablation was performed as usual.No patient complications were reported.
Event or Problem Description
It was reported that the array did not deploy properly.A 2.0cm x 15cm leveen superslim needle electrode was selected for use in a radiofrequency ablation procedure.During the procedure, a needle deployment failure occurred.When attempting to deploy the needle after the puncture, it did not open normally.The needle was removed.The needle size was changed to a 3.0cm x 15cm, and ablation was performed as usual.No patient complications were reported.

• 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: 19798290
• Report Number: 2124215-2024-44549
• Device Sequence Number: 11798570
• Product Code: GEI
• UDI-Device Identifier: 08714729441694
• UDI-Public: 08714729441694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113090
• 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): 09/12/2024

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: 08/06/2026
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0032164212
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• 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