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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device tube, drainage, suprapubic
Regulation Description Suprapubic urological catheter and accessories.
Product CodeFFA
Regulation Number 876.5090
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 74
Difficult to remove 31
Tear, rip or hole in device packaging 15
Foreign material present in device 14
Device damaged prior to use 10
Fracture 10
Detachment of device component 8
Entrapment of device or device component 7
Kinked 6
Migration of device or device component 6
Unsealed device packaging 6
Sticking 6
Device, or device fragments remain in patient 6
Detachment of device or device component 4
Device packaging compromised 4
Component(s), broken 4
Bent 4
Calcified 3
Difficult to position 3
Leak 3
Failure to advance 3
Split 2
Defective item 2
Device or device fragments location unknown 2
Device Issue 2
Difficult to open or remove packaging material 2
Dislodged or dislocated 2
No Known Device Problem 2
Packaging issue 2
Torn material 2
Occlusion within device 2
Peeled 2
Material separation 2
Tip breakage 2
Difficult to deploy 2
Dislodged 2
Fluid leak 1
Foreign material 1
Knotted 1
Hole in material 1
Material discolored 1
Material disintegration 1
Degraded 1
Air leak 1
Twisting 1
Uncoiled 1
Use of Device Issue 1
Material perforation 1
Shaft break 1
Shipping damage or problem 1
Sterility 1
Regenerate 1
Melted 1
Unintended movement 1
Positioning Issue 1
Material deformation 1
Difficult to advance 1
Device operates differently than expected 1
Tears, rips, holes in device, device material 1
Defective component 1
Failure to deliver 1
Wire(s), breakage of 1
Catheter withdrawal interference 1
Malposition of device 1
Delivery system failure 1
Physical resistance 1
Total Device Problems 287

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 1 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II May-21-2009

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