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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 192
Break 36
Detachment of device component 27
Difficult to remove 15
Device damaged prior to use 12
Failure to advance 12
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
Physical resistance 1
Use of Device Issue 1
Unknown (for use when the device problem is not known) 1
Defective component 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 344

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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