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

Model Number	36705
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Necrosis (1971)
Date of Event	04/02/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported ablation was performed in an unintended area.The patient was undergoing radiofrequency ablation (rfa) for treatment of liver cancer.A 2.0/17/15 leveen superslim needle was used and ablation was performed.However, it seemed the ablation was performed in an area slightly above where it should have been.There were no further complications reported.
Additional Manufacturer Narrative
Device eval by manufacturer: returned product analysis revealed one leveen needle electrode was received with its tines in closed/retracted position.No visual defects were noted, the returned product looks under good conditions without evidence of damages or anomalies.Residues were present indicating use and handling.Functional inspection revealed the handle was actuated moving it forward and backward and the tines could be extended and retracted properly without problems or resistance.
Event or Problem Description
It was reported ablation was performed in an unintended area.The patient was undergoing radiofrequency ablation (rfa) for treatment of liver cancer.A 2.0/17/15 leveen superslim needle was used and ablation was performed.However, it seemed the ablation was performed in an area slightly above where it should have been.There were no further complications 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: 8557539
• Report Number: 2134265-2019-04427
• Device Sequence Number: 19324844
• Product Code: GEI
• UDI-Device Identifier: 08714729441694
• UDI-Public: 08714729441694
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2021
• Device Model Number: 36705
• Device Catalogue Number: 36705
• Device Lot Number: 0022506041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 05/27/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other