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	11/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the array did not deploy properly.A 3.0 x 17 x 15 leveen superslim needle electrode was selected for use in a radio frequency ablation procedure in the liver.The device was used to puncture one patient in multiple locations.After the procedure was completed, the needle was deployed, and it was noticed that one of the needles was deployed outward in the opposite direction.The procedure was successfully completed with this device.No patient complications were reported.
Event or Problem Description
It was reported that the array did not deploy properly.A 3.0 x 17 x 15 leveen superslim needle electrode was selected for use in a radio frequency ablation procedure in the liver.The device was used to puncture one patient in multiple locations.After the procedure was completed, the needle was deployed, and it was noticed that one of the needles was deployed outward in the opposite direction.The procedure was successfully completed with this device.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was returned for analysis.No damage was observed at the handle.It was observed that the tines were bent.Consequently, the reported event was confirmed due to the condition of the device.

• 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: 18321730
• Report Number: 2124215-2023-70853
• Device Sequence Number: 15236311
• 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): 01/11/2024

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: 07/31/2026
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0032127476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 12/13/2023
• Supplement Report FDA Received Date: 01/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2023
• 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