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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device dilator, catheter, ureteral
Regulation Description Ureteral dilator.
Product CodeEZN
Regulation Number 876.5470
Device Class 2


Premarket Reviews
ManufacturerDecision
AMERICAN MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 9
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
COOK, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 5
MEADOX
  SUBSTANTIALLY EQUIVALENT 3
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
PRIMROSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RICHARD WOLF
  SUBSTANTIALLY EQUIVALENT 1
VANCE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Burst 57
Inflation issue 51
Leak 44
Balloon burst 42
Balloon rupture 26
Balloon leak(s) 25
Kinked 20
Hole in material 16
Device Issue 12
Balloon pinhole 10
Deflation issue 9
Tears, rips, holes in device, device material 9
Bent 9
Torn material 6
Break 5
Other (for use when an appropriate device code cannot be identified) 5
Material perforation 5
Defective item 5
Failure to advance 5
Device damaged prior to use 4
Material fragmentation 4
Material separation 3
Fitting problem 3
Material rupture 3
Difficult to remove 3
Tip breakage 2
Unknown (for use when the device problem is not known) 2
No Known Device Problem 2
Unsealed device packaging 2
Device packaging compromised 2
Material deformation 1
Decrease in pressure 1
Detachment of device component 1
Displacement 1
Unable to obtain readings 1
Difficult to advance 1
Device or device fragments location unknown 1
Detachment of device or device component 1
Reuse 1
Source, detachment from 1
Delivered as unsterile product 1
Pressure, insufficient 1
Device abrasion from instrument or another object 1
Mislabeled 1
Material puncture 1
Defective component 1
False reading from device non-compliance 1
Foreign material 1
Device operates differently than expected 1
Total Device Problems 410

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 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Apr-30-2008

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