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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device temporary coronary saphenous vein bypass graft for embolic protection
Regulation Description Percutaneous catheter.
Product CodeNFA
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 6
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
KENSEY NASH CORP.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
No Known Device Problem 114
Difficult to remove 94
Other (for use when an appropriate device code cannot be identified) 59
Unknown (for use when the device problem is not known) 47
Deflation issue 45
Deflation, cause unknown 44
Break 29
Detachment of device or device component 16
Detachment of device component 12
Wire(s), breakage of 11
Device damaged prior to use 10
Physical resistance 10
Kinked 10
Failure to advance 8
Device, or device fragments remain in patient 8
Not Applicable 7
Difficult to insert 6
Burst 6
Difficult to deploy 6
Entrapment of device or device component 6
Failure to capture 5
Source, detachment from 5
Use of Device Issue 5
Unintended movement 5
Tip breakage 4
Failure to deliver 4
Difficult to position 4
Hole in material 3
Device remains implanted 3
Material rupture 3
Material separation 3
Dislodged 3
Stretched 3
Device operates differently than expected 3
Material deformation 2
No Information 2
Positioning Issue 2
Torn material 2
Device, removal of (non-implant) 2
Traditional use 2
Tears, rips, holes in device, device material 2
Unraveled material 2
Failure to deploy 2
Shaft break 2
Inflation issue 2
Foreign material 2
Fracture 2
Material frayed 1
Device Difficult to Setup or Prepare 1
Increase in pressure 1
Material puncture 1
Retraction problem 1
Misapplication 1
Normal 1
Dissection 1
Device expiration issue 1
Filter break(s) 1
Flaked 1
Failure to flush 1
Difficult to fold or unfold 1
Footswitch failure 1
Collapse 1
Component(s), broken 1
Application interface becomes non-functional or program exits abnormally 1
Blockage within device or device component 1
Safety interlock(s) inadequate 1
Sterility 1
Sticking 1
Device Issue 1
Obstruction within device 1
Seal, defective 1
Material perforation 1
Deployment issue 1
Device markings issue 1
Malposition of device 1
Device or device fragments location unknown 1
Difficult to advance 1
Difficult to open or close 1
Total Device Problems 658

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 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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