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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, continuous flush
Regulation Description Continuous flush catheter.
Product CodeKRA
Regulation Number 870.1210
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT WITH DRUGS 1
  SUBSTANTIALLY EQUIVALENT 2
ARGON MEDICAL DEVICES INC.
  SUBSTANTIALLY EQUIVALENT 1
BACCHUS VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 7
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 3
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 13
CARDIMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 12
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 15
COVIDIEN
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
EKOS CORP.
  SE - WITH LIMITATIONS 2
  SUBSTANTIALLY EQUIVALENT 17
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLOWMEDICA, INC.
  SUBSTANTIALLY EQUIVALENT 3
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 3
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERCATOR MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 8
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 17
SCIMED
  SUBSTANTIALLY EQUIVALENT 6
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
VASCON LLC
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR DESIGNS INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 199
No Known Device Problem 120
Physical resistance 102
Obstruction within device 96
Detachment of device component 74
Aspiration issue 73
Material separation 60
Device displays error message 59
Burst 58
Balloon leak(s) 56
Fracture 53
Leak 50
Material rupture 40
Device damaged prior to use 37
No code available 37
Unknown (for use when the device problem is not known) 35
Inflation issue 34
Balloon burst 32
Difficult to remove 32
Hole in material 29
Detachment of device or device component 29
Other (for use when an appropriate device code cannot be identified) 28
Entrapment of device or device component 24
Dislodged or dislocated 22
Deflation issue 20
Mechanical issue 19
Peeled 19
Material integrity issue 19
Difficult to advance 16
Occlusion within device 16
Kinked 16
Interference 15
Foreign material present in device 14
Material fragmentation 13
Crack 13
Difficult to insert 12
Device or device component damaged by another device 12
Device operates differently than expected 11
Incorrect measurement 11
Failure to advance 10
Buckled material 9
Delamination 8
Tip breakage 7
Device inoperable 7
Flaked 7
Stretched 6
Device or device fragments location unknown 6
Device, or device fragments remain in patient 6
Torn material 6
Device markings issue 5
Shaft break 5
Balloon rupture 5
Blockage within device or device component 4
Failure to deploy 4
Disconnection 4
Fluid leak 4
Sticking 4
Use of Device Issue 4
Material perforation 4
Component missing 4
No Information 4
Positioning Issue 4
Device handling issue 3
Improper flow or infusion 3
No flow 3
Wire(s), breakage of 3
Split 3
Tube(s), defective 3
Fitting problem 3
Unraveled material 3
Resistance, inadequate 3
Unsealed device packaging 3
Premature deployment 3
Foreign material 3
Restricted flowrate 3
Measurements, inaccurate 3
Deflation, cause unknown 3
Device clogged 3
Component(s), broken 2
Air leak 2
Difficult to flush 2
Material frayed 2
Material puncture 2
Difficult to position 2
Device remains implanted 2
Loose or intermittent connection 2
Migration of device or device component 2
Device stops intermittently 2
Device Issue 2
Failure to deliver 1
Inaccurate delivery 1
Cut in material 1
Low readings 1
Delivery system failure 1
Deployment issue 1
Device packaging compromised 1
Device, removal of (non-implant) 1
Disinfection or Sterilization Issue at User Location 1
Connection issue 1
Blocked connection 1
Total Device Problems 1813

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 1 1 0
Class II 1 5 3 4 1 4 3 2 3 3 1
Class III 1 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Worldwide Headquarters II Feb-28-2012
2 Angiodynamics Worldwide Headquarters II Jan-11-2012
3 Angiodynamics Worldwide Headquarters II Sep-19-2011
4 Angiodynamics, Inc. II Aug-18-2014
5 Angiodynamics, Inc. II May-28-2010
6 Angiodynamics, Inc. II May-27-2010
7 Boston Scientific Corporation II Nov-15-2010
8 Boston Scientific Corporation II Sep-24-2009
9 Boston Scientific Corporation III Oct-31-2007
10 Cook Inc. II Mar-02-2017
11 Cook Inc. II Nov-06-2015
12 Cordis Corporation II Dec-30-2008
13 Covidien I Feb-03-2015
14 EKOS Corporation II Sep-21-2016
15 EKOS Corporation II Feb-24-2016
16 EKOS Corporation II Jul-20-2015
17 EKOS Corporation II Nov-01-2013
18 EKOS Corporation II Jul-17-2012
19 EKOS Corporation II Sep-16-2008
20 EKOS Corporation II Sep-02-2008
21 EKOS Corporation II Aug-20-2008
22 Edwards Lifesciences AG II Aug-25-2009
23 Edwards Lifesciences, LLC II Apr-18-2013
24 Edwards Lifesciences, Llc II Apr-17-2009
25 Ekos Corp II Mar-08-2007
26 Medtronic Inc. Cardiac Rhythm Disease Management II Apr-02-2015
27 Merit Medical Systems, Inc. II Oct-31-2014
28 Merit Medical Systems, Inc. II Dec-31-2013
29 Merit Medical Systems, Inc. II Mar-02-2010
30 Merit Medical Systems, Inc. II Sep-11-2008
31 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
32 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Sep-27-2012
33 Sequent Medical Inc II Oct-27-2016

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