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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter,intravascular,therapeutic,long-term greater than 30 days
Regulation Description Percutaneous, implanted, long-term intravascular catheter.
Product CodeLJS
Regulation Number 880.5970
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 9
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 12
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 2
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
BD
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 30
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
FLEXICATH LTD.
  SUBSTANTIALLY EQUIVALENT 1
FOOTPRINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 4
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
HORIZON MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERRAD MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 3
KLEIN-BAKER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
LUCENT MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 11
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 8
NORFOLK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PFM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 3
PMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
RITA MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
SMITHS
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
UTAH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 9
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 2

Device Problems
Leak 120
Break 52
Fracture 37
Migration of device or device component 37
Device, removal of (non-implant) 36
Material separation 27
Fluid leak 27
Unraveled material 21
Difficult to remove 20
Hole in material 16
Other (for use when an appropriate device code cannot be identified) 14
Component(s), broken 13
Crack 8
Material rupture 8
Material fragmentation 8
Device-device incompatibility 7
Human-Device Interface Issue 6
Difficult to insert 6
Split 5
Defective item 5
Detachment of device or device component 5
Device, or device fragments remain in patient 4
Blockage within device or device component 3
Decoupling 3
Knotted 3
Unknown (for use when the device problem is not known) 3
Torn material 3
Kinked 3
Entrapment of device or device component 3
Material frayed 3
Twisting 3
No Known Device Problem 3
Malposition of device 2
Difficult to advance 2
Material erosion 2
Occlusion within device 2
Use of Device Issue 2
No code available 2
Component missing 2
Failure to flush 2
Detachment of device component 2
Failure to advance 2
Burst 2
Physical resistance 2
Tears, rips, holes in device, device material 2
Uncoiled 1
Wire(s), breakage of 1
Failure to separate 1
Device operates differently than expected 1
Foreign material 1
Bent 1
Failure to obtain samples 1
Mushroomed 1
Rejection 1
Shaft break 1
Fitting problem 1
Slippage of device or device component 1
Stretched 1
Explanted 1
Implant, removal of 1
Inadequate user interface 1
Deployment issue 1
Percutaneous 1
Biofilm coating in device 1
Material Distortion 1
Total Device Problems 558

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 1 0 0
Class II 0 1 1 1 3 2 2
Class III 0 0 0 0 0 1 0

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Worldwide Headquarters II Feb-21-2012
2 Angiodynamics Worldwide Headquarters II Jan-26-2012
3 Angiodynamics Worldwide Headquarters III Jan-11-2012
4 Arrow International Inc II May-26-2010
5 Arrow International Inc II Jun-24-2009
6 Bard Access Systems II Jul-11-2011
7 Bard Access Systems II Jan-06-2011
8 Cook, Inc. I Feb-23-2011
9 Medical Components, Inc dba MedComp II Feb-28-2013
10 Medical Components, Inc dba MedComp II Sep-16-2008
11 Vygon Corporation II Mar-11-2013
12 Vygon Corporation II Jun-29-2011

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