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

Model Number	36719
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the needle had difficulty being extracted.A radio frequency ablation procedure was being performed on a hepatic carcinoma tumor for a patient.The leveen standard was being used for this procedure.When the needle was in position the physician performed the ablation of the tumor.After the ablation the physician had difficulty to close the device.Eventually the physician was able to close the device after using a very strong force with two hands.There were no patient complications.The patient condition was good.
Additional Manufacturer Narrative
Device evaluated by mfr: the leveen electrode was returned for analysis.No visual damages defects were observed on the electrode.A functional evaluation extended and retracted the tines without resistance.The tines were evenly spaced and undamaged.
Event or Problem Description
It was reported that the needle had difficulty being extracted.A radio frequency ablation procedure was being performed on a hepatic carcinoma tumor for a patient.The leveen standard was being used for this procedure.When the needle was in position the physician performed the ablation of the tumor.After the ablation the physician had difficulty to close the device.Eventually the physician was able to close the device after using a very strong force with two hands.There were no patient complications.The patient condition was good.

• Brand Name: LEVEEN STANDARD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8750924
• Report Number: 2134265-2019-07329
• Device Sequence Number: 19259574
• Product Code: GEI
• UDI-Device Identifier: 08714729300618
• UDI-Public: 08714729300618
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140496
• 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): 08/07/2019

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: 03/24/2022
• Device Model Number: 36719
• Device Catalogue Number: 36719
• Device Lot Number: 0023536553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 07/01/2019
• Supplement Report FDA Received Date: 08/07/2019
• Patient Sequence Number: 1