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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device prosthesis, esophageal
Regulation Description Esophageal prosthesis.
Product CodeESW
Regulation Number 878.3610
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 11
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR ARCHITECTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Migration of device or device component 179
Deployment issue 159
Failure to deploy 125
No code available 103
Other (for use when an appropriate device code cannot be identified) 91
Break 86
Blockage within device or device component 55
No Known Device Problem 45
Positioning Issue 41
Failure to expand 38
Difficult to remove 32
Fracture 28
Difficult to deploy 26
Difficult to position 25
Device damaged prior to use 24
Kinked 23
Detachment of device component 22
Occlusion within device 22
Suture line separation 22
Material integrity issue 21
Implant, removal of 20
Component(s), broken 20
Hole in material 18
Premature deployment 17
Device remains implanted 16
Unknown (for use when the device problem is not known) 14
Folded 13
Tears, rips, holes in device, device material 12
Detachment of device or device component 11
Failure to advance 10
Device Difficult to Setup or Prepare 8
Knotted 8
Bent 8
Explanted 7
Normal 7
Physical resistance 7
Torn material 6
Material deformation 6
Device, or device fragments remain in patient 6
Device Issue 6
Dislodged 6
Failure to discharge 5
Leak 5
Component missing 5
Unraveled material 5
Difficult to advance 5
Folding Issue 4
No Information 4
Use of Device Issue 4
Material perforation 4
Twisting 4
Obstruction within device 4
Material disintegration 4
Implant, repositioning of 3
Wire(s), breakage of 3
Deterioration of prosthesis 2
Defective component 2
Improper or incorrect procedure or method 2
Failure to unfold or unwrap 2
Unsealed device packaging 2
Suture line disruption 2
Size incorrect for patient 2
Displacement 2
Difficult to insert 2
Material invagination 2
Prep, failure to 2
Material frayed 2
Misplacement 2
Foreign material present in device 2
Misfire 2
Delivery System Issue, No Description 1
Device or device fragments location unknown 1
Sharp/jagged/rough/etched/scratched 1
Wrinkled 1
Difficult to open or close 1
Dislodged or dislocated 1
Expulsion 1
Device markings issue 1
Device operates differently than expected 1
Device packaging compromised 1
Patient Data Issue 1
Misassembled 1
Material puncture 1
Material fragmentation 1
Loose 1
Membrane leak(s) 1
Method, improper/incorrect 1
Flaked 1
Fluid leak 1
Footswitch failure 1
Battery charger, defective 1
Cuff degeneration 1
Source, detachment from 1
Tip breakage 1
Torqued 1
Peeled 1
Replace 1
Material rigid or stiff 1
Material separation 1
Shaft break 1
Total Device Problems 1512

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 2 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Aug-31-2010
2 Boston Scientific Corporation II Jun-25-2010

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