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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 166
Failure to deploy 122
Deployment issue 108
No code available 102
Other (for use when an appropriate device code cannot be identified) 91
Break 67
Blockage within device or device component 54
No Known Device Problem 42
Positioning Issue 33
Difficult to remove 28
Failure to expand 27
Difficult to deploy 26
Difficult to position 25
Device damaged prior to use 24
Fracture 23
Kinked 23
Occlusion within device 22
Suture line separation 22
Detachment of device component 21
Component(s), broken 20
Implant, removal of 20
Hole in material 17
Material integrity issue 17
Premature deployment 16
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
Failure to advance 10
Device Difficult to Setup or Prepare 8
Knotted 8
Bent 8
Explanted 7
Normal 7
Detachment of device or device component 7
Physical resistance 7
Torn material 6
Dislodged 6
Device Issue 6
Device, or device fragments remain in patient 6
Unraveled material 5
Failure to discharge 5
Leak 5
Difficult to advance 5
Component missing 5
Folding Issue 4
Material disintegration 4
Use of Device Issue 4
Obstruction within device 4
Twisting 4
Implant, repositioning of 3
Wire(s), breakage of 3
Material perforation 3
Improper or incorrect procedure or method 2
Failure to unfold or unwrap 2
Defective component 2
Deterioration of prosthesis 2
Misfire 2
Suture line disruption 2
Size incorrect for patient 2
Unsealed device packaging 2
Displacement 2
Difficult to insert 2
Material invagination 2
Material frayed 2
Misplacement 2
Prep, failure to 2
Foreign material present in device 2
Material deformation 2
No Information 2
Patient Data Issue 1
Delivery System Issue, No Description 1
Dislodged or dislocated 1
Expulsion 1
Device or device fragments location unknown 1
Sharp/jagged/rough/etched/scratched 1
Wrinkled 1
Device markings issue 1
Device operates differently than expected 1
Device packaging compromised 1
Material puncture 1
Misassembled 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
Peeled 1
Replace 1
Material rigid or stiff 1
Material separation 1
Shaft break 1
Source, detachment from 1
Tip breakage 1
Torqued 1
Seal, defective 1
Lens (IOL), migration of intraocular 1
Total Device Problems 1375

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 2 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 Aug-31-2010
2 Boston Scientific Corporation II Jun-25-2010

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