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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stent,metallic,expandable,duodenal
Regulation Description Esophageal prosthesis.
Product CodeMUM
Regulation Number 878.3610
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Break 67
Deployment issue 50
Failure to deploy 47
No code available 46
Other (for use when an appropriate device code cannot be identified) 42
Fracture 32
No Known Device Problem 31
Migration of device or device component 29
Positioning Issue 25
Obstruction within device 21
Blockage within device or device component 20
Kinked 16
Premature deployment 13
Detachment of device component 12
Difficult to deploy 11
Failure to expand 10
No Information 8
Bent 6
Component(s), broken 6
Difficult to remove 5
Detachment of device or device component 5
Failure to advance 4
Unknown (for use when the device problem is not known) 4
Material perforation 4
Device remains implanted 4
Occlusion within device 4
Difficult to position 4
Size incorrect for patient 3
Retraction problem 2
Device damaged prior to use 2
Implant, removal of 2
Handpiece break 2
Explanted 2
Collapse 2
Tears, rips, holes in device, device material 2
Delivery System Issue, No Description 2
Material deformation 2
Torn material 2
Material twisted 1
Packaging issue 1
Device misassembled during manufacturing or shipping 1
Difficult to advance 1
Delivery system failure 1
Tip breakage 1
Split 1
Physical resistance 1
Dislodged 1
Elective removal 1
Material fragmentation 1
Mislabeled 1
Misplacement 1
Normal 1
Difficult to insert 1
Device, or device fragments remain in patient 1
User used incorrect product for intended use 1
Material puncture 1
Shaft break 1
Source, detachment from 1
Stretched 1
Total Device Problems 570

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