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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 67
Difficult to remove 30
Tear, rip or hole in device packaging 14
Foreign material present in device 14
Device damaged prior to use 10
Fracture 10
Detachment of device component 8
Migration of device or device component 6
Unsealed device packaging 6
Sticking 6
Device, or device fragments remain in patient 6
Kinked 5
Entrapment of device or device component 5
Component(s), broken 4
Bent 4
Device packaging compromised 4
Detachment of device or device component 3
Failure to advance 3
Calcified 3
Difficult to position 3
Leak 3
Occlusion within device 2
Peeled 2
Material separation 2
Tip breakage 2
Difficult to deploy 2
Dislodged 2
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
Unintended movement 1
Positioning Issue 1
Material deformation 1
Device operates differently than expected 1
Difficult to advance 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
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
Total Device Problems 274

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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