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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, biliary, surgical
Regulation Description Biliary catheter and accessories.
Product CodeGCA
Regulation Number 876.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - KIT 1
TAUT
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Balloon burst 18
Inflation issue 15
Balloon rupture 14
Break 8
Burst 4
Split 3
Balloon leak(s) 3
Shipping damage or problem 2
Material perforation 1
Device damaged prior to use 1
Failure to advance 1
Physical resistance 1
Balloon pinhole 1
Foreign material present in device 1
Incorrect device or component shipped 1
Component(s), broken 1
Deflation, cause unknown 1
Deflation issue 1
Hole in material 1
Leak 1
Delivered as unsterile product 1
Difficult to remove 1
Total Device Problems 81

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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