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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 58
Failure to deploy 47
Other (for use when an appropriate device code cannot be identified) 42
No code available 42
Deployment issue 41
Fracture 27
No Known Device Problem 24
Positioning Issue 22
Migration of device or device component 22
Obstruction within device 21
Blockage within device or device component 13
Detachment of device component 12
Kinked 12
Premature deployment 12
Difficult to deploy 11
Bent 6
Component(s), broken 6
Failure to expand 6
No Information 5
Difficult to remove 5
Device remains implanted 4
Unknown (for use when the device problem is not known) 4
Material perforation 4
Difficult to position 4
Failure to advance 4
Size incorrect for patient 3
Occlusion within device 3
Retraction problem 2
Tears, rips, holes in device, device material 2
Device damaged prior to use 2
Implant, removal of 2
Explanted 2
Handpiece break 2
Collapse 2
Detachment of device or device component 2
Torn material 2
Delivery System Issue, No Description 2
Delivery system failure 1
Packaging issue 1
Device misassembled during manufacturing or shipping 1
Difficult to advance 1
Material deformation 1
Material twisted 1
Split 1
Physical resistance 1
Dislodged 1
Elective removal 1
Difficult to insert 1
Mislabeled 1
Misplacement 1
Normal 1
Tip breakage 1
Source, detachment from 1
Stretched 1
Shaft break 1
Device, or device fragments remain in patient 1
Material puncture 1
Total Device Problems 500

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