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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 0

Device Problems
Material rupture 315
Break 44
Detachment of device component 35
Device damaged prior to use 17
Failure to advance 16
Difficult to remove 16
Entrapment of device or device component 10
Detachment of device or device component 7
Deflation issue 7
Fracture 6
No Known Device Problem 5
Inflation issue 4
Leak 4
Hole in material 3
Kinked 3
Stretched 2
Fluid leak 2
Material deformation 2
Bent 2
Retraction problem 2
Unknown (for use when the device problem is not known) 1
Use of Device Issue 1
Replace 1
Burst 1
Device operates differently than expected 1
Physical resistance 1
Defective component 1
Size incorrect for patient 1
Foreign material present in device 1
Device or device component damaged by another device 1
Torn material 1
Difficult to advance 1
Total Device Problems 514

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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