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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Definition To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion.
Product CodeNWX
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
4 4 4 2 5 1 4 0 0 8 3

Device Problems
Material rupture 422
Break 50
Detachment of device component 40
Failure to advance 20
Device damaged prior to use 18
Difficult to remove 18
Entrapment of device or device component 11
Detachment of device or device component 10
Fracture 7
Deflation issue 7
Leak 6
Material deformation 6
No Known Device Problem 5
Inflation issue 4
Kinked 4
Hole in material 3
Fluid leak 3
Bent 2
Retraction problem 2
Difficult to advance 2
Stretched 2
Use of Device Issue 1
Unknown (for use when the device problem is not known) 1
Physical resistance 1
Defective component 1
Component missing 1
Tear, rip or hole in device packaging 1
Foreign material present in device 1
Device operates differently than expected 1
Device or device component damaged by another device 1
Torn material 1
Replace 1
Size incorrect for patient 1
Burst 1
Total Device Problems 655

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

Recalls
Manufacturer Recall Class Date Posted
1 AngioScore Inc. I Aug-18-2010
2 AngioScore Inc. III Jan-23-2008

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