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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 92
Other (for use when an appropriate device code cannot be identified) 59
Unknown (for use when the device problem is not known) 47
Deflation, cause unknown 44
Deflation issue 44
Break 29
Detachment of device component 12
Wire(s), breakage of 11
Device damaged prior to use 10
Physical resistance 10
Kinked 10
Device, or device fragments remain in patient 8
Failure to advance 8
Detachment of device or device component 7
Not Applicable 7
Difficult to insert 6
Entrapment of device or device component 6
Difficult to deploy 6
Burst 5
Failure to capture 5
Unintended movement 5
Use of Device Issue 5
Source, detachment from 5
Tip breakage 4
Failure to deliver 4
Difficult to position 4
Device remains implanted 3
Dislodged 3
Device operates differently than expected 3
Stretched 3
Material rupture 3
Material separation 3
Shaft break 2
Tears, rips, holes in device, device material 2
Unraveled material 2
Material deformation 2
Positioning Issue 2
Torn material 2
Device, removal of (non-implant) 2
Traditional use 2
Failure to deploy 2
Foreign material 2
Fracture 2
Hole in material 2
Inflation issue 2
No Information 2
Material frayed 1
Blockage within device or device component 1
Misapplication 1
Normal 1
Retraction problem 1
Device Difficult to Setup or Prepare 1
Increase in pressure 1
Material puncture 1
Collapse 1
Component(s), broken 1
Dissection 1
Application interface becomes non-functional or program exits abnormally 1
Device expiration issue 1
Filter break(s) 1
Flaked 1
Failure to flush 1
Footswitch failure 1
Deployment issue 1
Malposition of device 1
Device or device fragments location unknown 1
Difficult to advance 1
Difficult to open or close 1
Device markings issue 1
Sterility 1
Sticking 1
Safety interlock(s) inadequate 1
Material perforation 1
Seal, defective 1
Device Issue 1
Obstruction within device 1
Total Device Problems 643

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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