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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 56
Failure to deploy 47
Other (for use when an appropriate device code cannot be identified) 42
No code available 42
Deployment issue 41
Fracture 25
No Known Device Problem 23
Obstruction within device 21
Migration of device or device component 20
Positioning Issue 20
Blockage within device or device component 13
Detachment of device component 12
Kinked 12
Difficult to deploy 11
Premature deployment 10
Component(s), broken 6
Bent 6
No Information 5
Difficult to position 4
Material perforation 4
Device remains implanted 4
Difficult to remove 4
Failure to advance 4
Failure to expand 4
Unknown (for use when the device problem is not known) 4
Occlusion within device 3
Size incorrect for patient 3
Implant, removal of 2
Collapse 2
Torn material 2
Device damaged prior to use 2
Retraction problem 2
Explanted 2
Handpiece break 2
Tears, rips, holes in device, device material 2
Delivery System Issue, No Description 2
Material twisted 1
Physical resistance 1
Device, or device fragments remain in patient 1
Tip breakage 1
Elective removal 1
Mislabeled 1
Material puncture 1
Difficult to advance 1
Difficult to insert 1
Source, detachment from 1
Stretched 1
Split 1
Delivery system failure 1
Detachment of device or device component 1
Packaging issue 1
Device misassembled during manufacturing or shipping 1
Dislodged 1
Misplacement 1
Normal 1
Shaft break 1
Total Device Problems 484

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