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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device drug-eluting peripheral transluminal angioplasty catheter
Definition A drug-eluting peripheral transluminal angioplasty catheter is a combination product intended for balloon dilatation of peripheral vasculature to establish or maintain patency. A drug-eluting PTA catheter delivers a drug to the vessel as part of the angioplasty procedure and is intended to inhibit restenosis. Intended to provide percutaneous transluminal angioplasty of lesions in peripheral arteries including iliac, popliteal, infrapopliteal, femoral, and iliofemoral.
Product CodeONU
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 0 0 2 17 23 13

Device Problems
No Known Device Problem 853
Material rupture 68
Defective item 64
Inflation issue 45
Burst 19
Difficult to remove 13
Deflation issue 12
Detachment of device or device component 9
Occlusion within device 6
Device expiration issue 5
Device-device incompatibility 5
Difficult to advance 5
Retraction problem 4
Torn material 4
Leak 3
Stretched 2
Material deformation 2
No Information 2
Scratched material 2
Device operates differently than expected 1
Kinked 1
Crack 1
Total Device Problems 1126

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