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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, cholangiography
Regulation Description Introduction/drainage catheter and accessories.
Product CodeGBZ
Regulation Number 878.4200
Device Class 1


Premarket Reviews
ManufacturerDecision
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 3
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
ETHICON
  SUBSTANTIALLY EQUIVALENT 1
LIFESTREAM INT'L, INC.
  SUBSTANTIALLY EQUIVALENT 1
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT - KIT 1
TAUT
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material separation 14
Other (for use when an appropriate device code cannot be identified) 10
Misassembled 5
Device, or device fragments remain in patient 3
Inflation issue 3
Balloon rupture 3
Break 3
Detachment of device component 3
Migration of device or device component 2
Tip breakage 2
Unraveled material 2
Device, removal of (non-implant) 2
Detachment of device or device component 2
Device packaging compromised 2
Tear, rip or hole in device packaging 2
Product quality issue 2
Malfunction 1
Physical resistance 1
Improper flow or infusion 1
Material Protrusion 1
No Known Device Problem 1
No Information 1
Device handling issue 1
Device markings issue 1
Device operates differently than expected 1
Fitting problem 1
Sterility 1
Component missing 1
Incomplete or missing packaging 1
Radiation overexposure 1
Air leak 1
Difficult to insert 1
Material rupture 1
Occlusion within device 1
Unsealed device packaging 1
Dissection 1
Explanted 1
Foreign material 1
Burst 1
Component(s), broken 1
Blockage within device or device component 1
Total Device Problems 85

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 1 0 0 0 0 0 1 3 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 American Catheter Corp II Jul-22-2015
2 Atrium Medical Corporation II Aug-05-2015
3 Atrium Medical Corporation II Aug-14-2008
4 Cook Inc. II Jul-18-2015
5 Teleflex Medical II Jun-12-2014

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