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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 4

Device Problems
No Known Device Problem 1152
Difficult to remove 185
Leak 90
Kinked 88
Torn material 29
Air leak 29
Bent 21
Difficult to open or close 11
Detachment of device or device component 10
Material deformation 6
Hole in material 6
Premature deployment 5
Deployment issue 5
Detachment of device component 4
Break 3
Material separation 3
Foreign material present in device 3
Material Protrusion 2
Physical resistance 2
Disinfection or Sterilization Issue at User Location 2
Difficult to open or remove packaging material 2
Size incorrect for patient 2
Crack 2
Difficult to deploy 2
Entrapment of device or device component 1
Fluid leak 1
Difficult to flush 1
Fracture 1
Material fragmentation 1
Contamination during use 1
Device damaged prior to use 1
Tear, rip or hole in device packaging 1
Failure to advance 1
Split 1
Material puncture 1
Difficult to insert 1
Device or device component damaged by another device 1
Difficult to advance 1
Positioning Issue 1
Unintended movement 1
Total Device Problems 1680

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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