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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 61
Failure to deploy 47
Deployment issue 43
No code available 42
Other (for use when an appropriate device code cannot be identified) 42
Fracture 29
No Known Device Problem 24
Migration of device or device component 23
Positioning Issue 23
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
Failure to expand 6
Bent 6
Component(s), broken 6
No Information 6
Difficult to remove 5
Failure to advance 4
Unknown (for use when the device problem is not known) 4
Difficult to position 4
Material perforation 4
Device remains implanted 4
Size incorrect for patient 3
Detachment of device or device component 3
Occlusion within device 3
Retraction problem 2
Explanted 2
Handpiece break 2
Tears, rips, holes in device, device material 2
Delivery System Issue, No Description 2
Collapse 2
Torn material 2
Implant, removal of 2
Device damaged prior to use 2
Material deformation 2
Device misassembled during manufacturing or shipping 1
Misplacement 1
Shaft break 1
Normal 1
Dislodged 1
Difficult to advance 1
Difficult to insert 1
Stretched 1
Source, detachment from 1
Split 1
Delivery system failure 1
Packaging issue 1
Physical resistance 1
Material twisted 1
Device, or device fragments remain in patient 1
Elective removal 1
Tip breakage 1
Material puncture 1
Mislabeled 1
Total Device Problems 512

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