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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 8
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 3
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 5
  SUBSTANTIALLY EQUIVALENT - KIT 1
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 52
Inflation issue 50
Leak 44
Balloon burst 41
Balloon leak(s) 25
Balloon rupture 24
Kinked 16
Hole in material 16
Device Issue 12
Balloon pinhole 10
Tears, rips, holes in device, device material 9
Bent 8
Deflation issue 7
Failure to advance 5
Defective item 5
Torn material 5
Material fragmentation 4
Other (for use when an appropriate device code cannot be identified) 4
Material perforation 4
Device damaged prior to use 4
Fitting problem 3
Break 3
Unknown (for use when the device problem is not known) 2
Unsealed device packaging 2
Difficult to remove 2
Material separation 2
Device packaging compromised 2
Material deformation 1
No Known Device Problem 1
Detachment of device or device component 1
Device operates differently than expected 1
Device or device fragments location unknown 1
Pressure, insufficient 1
Source, detachment from 1
Reuse 1
Material rupture 1
Decrease in pressure 1
Unable to obtain readings 1
Defective component 1
Tip breakage 1
Displacement 1
False reading from device non-compliance 1
Foreign material 1
Detachment of device component 1
Device abrasion from instrument or another object 1
Mislabeled 1
Delivered as unsterile product 1
Total Device Problems 381

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