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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
4 4 4 2 5 1 4 0 0 2

Device Problems
Material rupture 177
Break 34
Detachment of device component 24
Difficult to remove 12
Device damaged prior to use 11
Failure to advance 11
Entrapment of device or device component 8
Detachment of device or device component 6
Fracture 4
Hole in material 3
Deflation issue 2
Kinked 2
Leak 2
Bent 2
Retraction problem 2
Stretched 2
Material deformation 2
No Known Device Problem 2
Torn material 1
Use of Device Issue 1
Unknown (for use when the device problem is not known) 1
Physical resistance 1
Device operates differently than expected 1
Device or device component damaged by another device 1
Difficult to advance 1
Size incorrect for patient 1
Replace 1
Burst 1
Inflation issue 1
Fluid leak 1
Total Device Problems 318

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