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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device agent, injectable, embolic
Product CodeMFE
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
1 0 0 0 0 1 2 1 1 1

Device Problems
No Known Device Problem 39
Detachment of device component 9
Entrapment of device or device component 9
No code available 7
Unknown (for use when the device problem is not known) 5
Migration of device or device component 4
Burst 4
Other (for use when an appropriate device code cannot be identified) 4
Leak 3
Break 3
Therapy delivered to incorrect body area 3
Device operates differently than expected 3
Burn of device or device component 2
User used incorrect product for intended use 2
Reflux within device 1
Device remains implanted 1
Device, or device fragments remain in patient 1
Difficult to remove 1
Incorrect or inadequate result 1
Material rupture 1
Material separation 1
Sticking 1
Improper or incorrect procedure or method 1
Failure to separate 1
Malposition of device 1
Optical issue 1
Not Applicable 1
No Information 1
Total Device Problems 111

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