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

Model Number	36705
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned with its original pouch.Overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The device was inspected according to procedures.Visual inspection: one rf probe was returned for analysis (electrode).No issues were observed with the insulation in the electrode.The tip of the electrode was bent (distal section).Functional inspection: a functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.The reported complaint is confirmed.
Event or Problem Description
It was reported that tip damage occurred.During a radio frequency ablation (rfa) procedure, a leveen needle electrode was used.When the package was opened, the tip of the leveen needle electrode was damaged.The device was used in the patient after noting the tip damage and the procedure was completed.

• 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: 11275684
• Report Number: 2134265-2021-01063
• Device Sequence Number: 14522975
• Product Code: GEI
• UDI-Device Identifier: 08714729441694
• UDI-Public: 08714729441694
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/03/2021

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: 11/04/2023
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0026300580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 02/03/2021
• Patient Sequence Number: 1
• Patient Age: 65 YR