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	05/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported there was severe resistance.A 2.0/17/25 leveen needle electrode was selected for use to treat liver cancer.After puncture with the needle, there was severe resistance while advancing.Usage was discontinued.A different device was selected to complete the procedure.There were no patient complications.

• Brand Name: LEVEEN SUPERSLIM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11979318
• Report Number: 2134265-2021-07477
• Device Sequence Number: 17010338
• Product Code: GEI
• UDI-Device Identifier: 08714729441700
• UDI-Public: 08714729441700
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K113091
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2021

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: 03/04/2023
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0025304781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 06/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1