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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device port & catheter, implanted, subcutaneous, intravascular
Regulation Description Subcutaneous, implanted, intravascular infusion port and catheter.
Product CodeLJT
Regulation Number 880.5965
Device Class 2


Premarket Reviews
ManufacturerDecision
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 9
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 8
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 22
CLINICAL PLASTIC PRODUCTS SA
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
GRANTADLER CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 3
HORIZON MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 6
  SUBSTANTIALLY EQUIVALENT - KIT 5
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
MED INSTITUTE, INC.
  SUBSTANTIALLY EQUIVALENT 16
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 1
NORFOLK MEDICAL
  SUBSTANTIALLY EQUIVALENT 16
PFM MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 3
RITA MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 15
  1.  K010426  PROPORT PLASTIC VENOUS IMPLANTABLE ACCESS SYSTEMS ...
  2.  K033686  PORT-A-CATH II REGIONAL ARTERIAL PORTAL SYSTEM
  3.  K060036  PORT-A-CATH, PORT-A-CATH II, PROPORT AND P.A.S. PO ...
  4.  K070116  POWER PORT-A-CATH AND POWER PORT-A-CATH II; IMPLAN ...
  5.  K072657  POWER PORT-A-CATH, CATH II, AND P.A.S. PORT T2 POW ...
  6.  K093414  PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS ...
  7.  K935767  SIMS SILO NEEDLE DE-ACCESS ENCLOSURE
  8.  K955407  PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS
  9.  K961580  PORT-A-CATH P.A.S. PORT II IMPLANTABLE VENOUS ACCE ...
  10.  K962695  PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS P ...
  11.  K973862  PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS
  12.  K974471  PORT-A-CATH- II DUAL-LUMEN LOW PROFILE SYSTEM, POR ...
  13.  K992697  PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
  14.  K992880  P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
  15.  K994216  PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
STD MED, INC.
  SUBSTANTIALLY EQUIVALENT 2
TRISTATE
  SUBSTANTIALLY EQUIVALENT - KIT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fracture 58
Break 18
Leak 12
Suction issue 11
Explanted 11
Implant, removal of 8
Detachment of device component 8
Failure to separate 8
Migration of device or device component 7
Device inoperable 6
Difficult to remove 5
Material fragmentation 4
Device, removal of (non-implant) 4
Port leak(s) 3
Device, or device fragments remain in patient 3
Device Issue 3
Hole in material 3
Tears, rips, holes in device, device material 3
Defective item 3
Difficult to flush 3
Source, detachment from 3
Obstruction within device 2
Crack 2
Degraded 2
Unknown (for use when the device problem is not known) 2
Disconnection 2
Occlusion within device 2
Unraveled material 2
Malfunction 2
Kinked 2
Material separation 2
Decoupling 2
Failure to infuse 2
Defective component 1
Material integrity issue 1
Device maintenance issue 1
Dislodged 1
Improper or incorrect procedure or method 1
Runaway 1
Device clogged 1
Device remains implanted 1
Catheter withdrawal interference 1
Inflation issue 1
Reaction 1
Malposition of device 1
Entrapment of device or device component 1
Replace 1
Implant, repositioning of 1
Device or device fragments location unknown 1
Failure to deliver 1
Failure to flush 1
Stretched 1
Slippage of device or device component 1
Use of Device Issue 1
Retraction problem 1
Disassembly 1
Deployment issue 1
No Information 1
Component(s), broken 1
Difficult to position 1
Total Device Problems 235

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

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, INC II Aug-24-2011
2 Angiodynamics, INC II Sep-01-2009
3 B. Braun Interventional Systems II Jun-27-2011
4 B. Braun Interventional Systems II Sep-03-2009
5 Bard Access Systems III Mar-01-2012
6 Bard Access Systems II Apr-29-2010
7 Boston Scientific Corp II Apr-14-2007
8 Boston Scientific Corp II Mar-15-2007
9 Cook Vascular Inc. II Sep-17-2008
10 Cook, Inc. I Feb-23-2011
11 Medical Components, Inc dba MedComp II Jun-26-2012
12 Medical Components, Inc dba MedComp II May-18-2012
13 Medical Components, Inc dba MedComp II Aug-17-2010
14 Navilyst Medical, Inc I Jul-01-2010
15 Rita Medical Systems, Inc. II Dec-28-2007

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