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

Model Number	36705
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event approximated since unknown.
Event or Problem Description
It was reported that the coating on the tip of the needle was deformed during preparation for a radiofrequency ablation procedure.During preparation of the leveen superslim needle electrode; the coating on the tip of the needle was deformed.The procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Date of event approximated since unknown.Device evaluated by mfr: the unit returned has an unknown cover in the tip, as part of overall visual revision.The returned device matches with upn provided by the customer.One rf probe was returned for analysis.No visual damages were observed on the electrode, handle, cannula and the insulated area.The insulation coating was not damaged.A foreign matter was observed adhered to the needle tip.A functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.Foreign matters were also observed adhered to the tines.
Event or Problem Description
It was reported that the coating on the tip of the needle was deformed during preparation for a radiofrequency ablation procedure.During preparation of the leveen superslim needle electrode; the coating on the tip of the needle was deformed.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 8565131
• Report Number: 2134265-2019-04449
• Device Sequence Number: 2207548
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: 12/13/2021
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0023086983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1