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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 885
Difficult to remove 152
Leak 76
Kinked 64
Torn material 25
Air leak 25
Bent 18
Difficult to open or close 11
Detachment of device or device component 9
Material deformation 6
Premature deployment 4
Hole in material 4
Material separation 3
Break 3
Foreign material present in device 3
Deployment issue 3
Physical resistance 2
Disinfection or Sterilization Issue at User Location 2
Material Protrusion 2
Crack 2
Difficult to deploy 1
Entrapment of device or device component 1
Fluid leak 1
Difficult to flush 1
Fracture 1
Material fragmentation 1
Detachment of device component 1
Size incorrect for patient 1
Device damaged prior to use 1
Failure to advance 1
Split 1
Difficult to insert 1
Material puncture 1
Unintended movement 1
Device or device component damaged by another device 1
Difficult to advance 1
Difficult to open or remove packaging material 1
Total Device Problems 1316

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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