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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 - KIT 1
  SUBSTANTIALLY EQUIVALENT 2
TAUT
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Balloon burst 18
Inflation issue 15
Balloon rupture 14
Material separation 11
Burst 9
Material Protrusion 9
Break 8
Deflation issue 5
Balloon leak(s) 3
Split 3
Shipping damage or problem 2
Hole in material 2
Detachment of device component 2
Migration of device or device component 2
Delivered as unsterile product 1
Difficult to remove 1
Shelf life exceeded 1
Fracture 1
Leak 1
Deflation, cause unknown 1
Component(s), broken 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
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
Total Device Problems 119

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015

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