MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER EVIDENT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	VTGEN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Fistula (1862); Urinary Tract Infection (2120); Obstruction/Occlusion (2422); Burn, Thermal (2530)
Date of Event	06/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Title mwa versus rfa for perivascular and peribiliary crlm: a retrospective patient- and lesion-based analysis of two historical cohorts source cardiovasc intervent radiol.39 (9) (1438¿1446), 2016.Date of publication: 25 jun 2016.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of study performed 25 june 2016,this is a retrospective study to analyze the safety and efficacy of radiofrequency ablation (rfa) versus microwave ablation (mwa) in the treatment of unresectable colorectal liver metastases (crlm) in proximity to large vessels and/ or major bile ducts.For mwa, they used 3.7- cm microwave antenna(s) (evident, covidien, dublin, ireland).Complications for patients with mwa were as follows: related to probe injury and occurring in 3.1% (1/32 lesions) each: pneumothorax, hepatic hemorrhage; related to thermal injury and occurring in 3.1% (1/32 lesions) each: fever, pain and fever, subphrenical abscess, biliary obstruction, and biliopleural fistula; related to the general procedure and occurring in 3.1% (1/32 lesions) each: urinary tract infection, plexus brachialis neuralgia, and benign cardiac arrythmia; and related to thermal injury and occurring in 6.2% (2/32 lesions): biloma/biliary leakage.

• Brand Name: EVIDENT
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8245919
• Report Number: 1717344-2019-00087
• Device Sequence Number: 2202658
• Product Code: NEY
• UDI-Device Identifier: 10884524001579
• UDI-Public: 10884524001579
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K011676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/14/2019

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 Model Number: VTGEN
• Device Catalogue Number: VTGEN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR