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

Model Number	36700
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tines became bent.A radio frequency ablation procedure was being performed on a tumor for a patient with liver cancer.The leveen coaccess was being used for this procedure.When the physician was using the device the tines became bent.The device was removed from the patient and the procedure was completed with another of the same device.There were no patient complications that were reported.
Event or Problem Description
It was reported that the tines became bent.A radio frequency ablation procedure was being performed on a tumor for a patient with liver cancer.The leveen coaccess was being used for this procedure.When the physician was using the device the tines became bent.The device was removed from the patient and the procedure was completed with another of the same device.There were no patient complications that were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the electrode was returned for analysis.No visual damages defects were observed on the electrode, handle, cannula and connector.Residues observed on the device indicated use and handling of the device.A functional evaluation extended and retracted the tines without resistance, after the tines were extended it was noticed that some of them were bent.

• Brand Name: LEVEEN COACCESS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9490037
• Report Number: 2134265-2019-15581
• Device Sequence Number: 2981685
• Product Code: GEI
• UDI-Device Identifier: 08714729295617
• UDI-Public: 08714729295617
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K140505
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2020

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: 04/08/2022
• Device Model Number: 36700
• Device Catalogue Number: 36700
• Device Lot Number: 0023616086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 02/10/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 02/27/2020
• Patient Sequence Number: 1