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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, appendage closure, left atrial
Product CodeNGV
Device Class Not Classified

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 0 0 0 4 8 2

Device Problems
No Known Device Problem 817
Difficult to remove 142
Leak 71
Kinked 58
Torn material 25
Air leak 23
Bent 17
Difficult to open or close 10
Detachment of device or device component 8
Material deformation 6
Premature deployment 4
Hole in material 3
Break 3
Deployment issue 3
Foreign material present in device 2
Disinfection or Sterilization Issue at User Location 2
Material Protrusion 2
Unintended movement 1
Device or device component damaged by another device 1
Difficult to open or remove packaging material 1
Detachment of device component 1
Crack 1
Difficult to deploy 1
Entrapment of device or device component 1
Fluid leak 1
Difficult to flush 1
Material fragmentation 1
Difficult to insert 1
Material puncture 1
Material separation 1
Size incorrect for patient 1
Device damaged prior to use 1
Failure to advance 1
Split 1
Physical resistance 1
Total Device Problems 1214

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Nov-11-2015

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