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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 4

Device Problems
Material rupture 229
Break 39
Detachment of device component 31
Difficult to remove 15
Device damaged prior to use 14
Failure to advance 13
Entrapment of device or device component 9
Detachment of device or device component 6
Fracture 5
Hole in material 3
Deflation issue 3
Kinked 3
Leak 3
No Known Device Problem 3
Material deformation 2
Stretched 2
Bent 2
Retraction problem 2
Size incorrect for patient 1
Replace 1
Burst 1
Inflation issue 1
Fluid leak 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
Torn material 1
Physical resistance 1
Total Device Problems 397

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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