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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 115
Difficult to remove 96
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 30
Detachment of device or device component 27
Detachment of device component 12
Wire(s), breakage of 11
Device damaged prior to use 10
Kinked 10
Physical resistance 9
Failure to advance 8
Device, or device fragments remain in patient 8
Difficult to insert 7
Not Applicable 7
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
Material deformation 4
Tip breakage 4
Material rupture 4
Failure to deliver 4
Hole in material 4
Difficult to position 4
Inflation issue 3
Fracture 3
Dislodged 3
Material separation 3
Device remains implanted 3
Stretched 3
Torn material 3
Device operates differently than expected 3
Positioning Issue 2
Tears, rips, holes in device, device material 2
Unraveled material 2
Shaft break 2
Device, removal of (non-implant) 2
Traditional use 2
Failure to deploy 2
Difficult to fold or unfold 2
Foreign material 2
Footswitch failure 1
Material frayed 1
Device Difficult to Setup or Prepare 1
Increase in pressure 1
Material puncture 1
Leak 1
Migration of device or device component 1
Misapplication 1
Normal 1
Unsealed device packaging 1
Dissection 1
Device expiration issue 1
Filter break(s) 1
Flaked 1
Failure to flush 1
Collapse 1
Component(s), broken 1
Application interface becomes non-functional or program exits abnormally 1
Blockage within device or device component 1
Patient-device incompatibility 1
Aspiration issue 1
Component or accessory incompatibility 1
Deployment issue 1
Malposition of device 1
Device markings issue 1
Device or device fragments location unknown 1
Seal, defective 1
Device Issue 1
Obstruction within device 1
Sterility 1
Sticking 1
Retraction problem 1
Safety interlock(s) inadequate 1
Material perforation 1
Device or device component damaged by another device 1
Difficult to open or close 1
No Information 1
Total Device Problems 686

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


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