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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 63
Difficult to remove 30
Tear, rip or hole in device packaging 14
Foreign material present in device 14
Fracture 10
Device damaged prior to use 9
Sticking 6
Detachment of device component 6
Unsealed device packaging 6
Migration of device or device component 6
Device, or device fragments remain in patient 6
Kinked 5
Entrapment of device or device component 4
Component(s), broken 4
Bent 4
Calcified 3
Failure to advance 3
Difficult to position 3
Device packaging compromised 3
Leak 3
Peeled 2
Dislodged 2
Device Issue 2
Material separation 2
Split 2
Defective item 2
Device or device fragments location unknown 2
Detachment of device or device component 2
Difficult to open or remove packaging material 2
Packaging issue 2
Torn material 2
Tip breakage 2
Difficult to deploy 2
Occlusion within device 2
No Known Device Problem 2
Dislodged or dislocated 2
Degraded 1
Melted 1
Shipping damage or problem 1
Use of Device Issue 1
Failure to deliver 1
Regenerate 1
Twisting 1
Defective component 1
Material disintegration 1
Foreign material 1
Sterility 1
Tears, rips, holes in device, device material 1
Uncoiled 1
Physical resistance 1
Delivery system failure 1
Material perforation 1
Fluid leak 1
Malposition of device 1
Difficult to advance 1
Positioning Issue 1
Wire(s), breakage of 1
Air leak 1
Hole in material 1
Catheter withdrawal interference 1
Knotted 1
Shaft break 1
Material deformation 1
Unintended movement 1
Total Device Problems 262

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