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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 80
Difficult to remove 32
Tear, rip or hole in device packaging 16
Foreign material present in device 15
Device damaged prior to use 10
Fracture 10
Detachment of device component 9
Migration of device or device component 9
Occlusion within device 7
Entrapment of device or device component 7
Kinked 6
Unsealed device packaging 6
Device, or device fragments remain in patient 6
Sticking 6
Device packaging compromised 6
Detachment of device or device component 5
No Known Device Problem 5
Dislodged or dislocated 4
Leak 4
Calcified 4
Component(s), broken 4
Bent 4
Peeled 3
Difficult to position 3
Device operates differently than expected 3
Failure to advance 3
Split 2
Defective item 2
Device or device fragments location unknown 2
Packaging issue 2
Torn material 2
Device Issue 2
Difficult to open or remove packaging material 2
Material separation 2
Dislodged 2
Tip breakage 2
Difficult to deploy 2
Material discolored 1
Material disintegration 1
Degraded 1
Air leak 1
Melted 1
Knotted 1
Fluid leak 1
Foreign material 1
Hole in material 1
Twisting 1
Uncoiled 1
Use of Device Issue 1
Material perforation 1
Tears, rips, holes in device, device material 1
Shaft break 1
Shipping damage or problem 1
Sterility 1
Regenerate 1
Material deformation 1
Unintended movement 1
Positioning Issue 1
Catheter withdrawal interference 1
Malposition of device 1
Delivery system failure 1
Difficult to advance 1
Physical resistance 1
Defective component 1
Failure to deliver 1
Wire(s), breakage of 1
Total Device Problems 318

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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