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 Consequences Or Impact To Patient (2199)
Date of Event	04/17/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle was damaged.A radio frequency ablation procedure was being performed on a tumor for a patient with liver cancer.The leveen superslim was being used for this procedure.During the procedure the needle was found to be deformed after ablation of the needle canal.This device was removed from the patient and a new needle was used to successfully complete the procedure.There were no patient complications that were reported and the patient was doing fine.
Additional Manufacturer Narrative
Unit returned with its original box, overall visual revision did not identify failures or evidence that could be lost due to decontamination process.The returned device matches with upn provided by the customer.Visual inspection the electrode and cable were returned for analysis.No visual damages defects were observed on the cable, electrode, handle, cannula and connector.Residues observed on the device indicated use and handling of the device.Functional inspection a functional evaluation extended and retracted the tines without resistance, after the tines were extended it was noticed that some of them were bent.
Event or Problem Description
It was reported that the needle was damaged.A radio frequency ablation procedure was being performed on a tumor for a patient with liver cancer.The leveen superslim was being used for this procedure.During the procedure the needle was found to be deformed after ablation of the needle canal.This device was removed from the patient and a new needle was used to successfully complete the procedure.There were no patient complications that were reported and the patient was doing fine.

• 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: 10053643
• Report Number: 2134265-2020-06109
• Device Sequence Number: 16839841
• Product Code: GEI
• UDI-Device Identifier: 08714729441694
• UDI-Public: 08714729441694
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113090
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2020

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: 07/28/2022
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0024179049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Initial Date Received by Manufacturer: 04/21/2020
• Supplement Date Received by Manufacturer: 06/18/2020
• Initial Report FDA Received Date: 05/13/2020
• Supplement Report FDA Received Date: 06/23/2020
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 72