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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER EVIDENT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
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COVIDIEN MFG DC BOULDER EVIDENT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES Back to Search Results
Model Number VTGEN
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Hemoptysis (1887); Pleural Effusion (2010); Pneumothorax (2012)
Date of Event 11/15/2013
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Title microwave ablation of lung tumours: single-centre preliminary experience source radiol med.119 (8) (75¿82), 2014.Date of publication: 21 jun 2013.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the literature source performed.After being treated of microwave (mw) ablation of lung tumors asymptomatic grade-1 pneumothorax was recorded in 9 patients (37.5 %).One case of asymptomatic pleural effusion and one of haemoptysis, not requiring transfusion, were observed.
 
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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 Key8246052
Report Number1717344-2019-00088
Device Sequence Number1697303
Product Code NEY
UDI-Device Identifier10884524001579
UDI-Public10884524001579
Combination Product (Y/N)N
Initial Reporter CountryIT
PMA/510(K) Number
K011676
Number of Events Summarized1
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 NumberVTGEN
Device Catalogue NumberVTGEN
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 Date01/14/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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