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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 1

Device Problems
Material rupture 338
Break 45
Detachment of device component 36
Device damaged prior to use 18
Failure to advance 16
Difficult to remove 16
Entrapment of device or device component 10
Detachment of device or device component 8
Fracture 7
Deflation issue 7
Leak 5
No Known Device Problem 5
Inflation issue 4
Kinked 3
Hole in material 3
Fluid leak 3
Bent 2
Retraction problem 2
Material deformation 2
Stretched 2
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
Foreign material present in device 1
Physical resistance 1
Torn material 1
Replace 1
Size incorrect for patient 1
Burst 1
Total Device Problems 544

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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