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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 0

Device Problems
Material rupture 157
Break 33
Detachment of device component 23
Difficult to remove 11
Device damaged prior to use 10
Failure to advance 9
Entrapment of device or device component 7
Detachment of device or device component 6
Fracture 3
Hole in material 3
Deflation issue 2
Kinked 2
Leak 2
Bent 2
Retraction problem 2
Material deformation 2
No Known Device Problem 2
Stretched 2
Use of Device Issue 1
Unknown (for use when the device problem is not known) 1
Physical resistance 1
Torn material 1
Device operates differently than expected 1
Difficult to advance 1
Size incorrect for patient 1
Replace 1
Burst 1
Inflation issue 1
Total Device Problems 288

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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