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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, intravascular, diagnostic
Regulation Description Diagnostic intravascular catheter.
Product CodeDQO
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT
  SUBSTANTIALLY EQUIVALENT 9
ACIST MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
ACUSON
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 6
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 7
ANGIOMETRX INC.
  SUBSTANTIALLY EQUIVALENT 2
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 2
ASAHI
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 5
BIOSENSORS
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSORS INTL. PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 2
BIOSPHERE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 38
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 16
COBE INC.
  SUBSTANTIALLY EQUIVALENT 1
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 4
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 31
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 2
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 2
HARMAC MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 2
ICU MEDICAL SALES, INC.
  SUBSTANTIALLY EQUIVALENT 2
INFRAREDX, INC.
  SUBSTANTIALLY EQUIVALENT 1
IRVINE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
JOMED
  SUBSTANTIALLY EQUIVALENT 1
KERBEROS PROXIMAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 1
LIFESTREAM INT'L, INC.
  SUBSTANTIALLY EQUIVALENT 1
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 4
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEADOX
  SUBSTANTIALLY EQUIVALENT 1
MEDEX
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDLINE
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRUS
  SUBSTANTIALLY EQUIVALENT 7
MILLAR INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
NAMIC
  SUBSTANTIALLY EQUIVALENT 2
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
NOVOSTE CORP
  SUBSTANTIALLY EQUIVALENT 3
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 5
ORIGEN BIOMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCIMED
  SUBSTANTIALLY EQUIVALENT 18
SEDAT
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 7
THEROX, INC.
  SUBSTANTIALLY EQUIVALENT 1
TRINITY
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 10

Device Problems
Difficult to remove 290
Material separation 241
Break 239
Other (for use when an appropriate device code cannot be identified) 149
Unraveled material 134
Tip breakage 109
Difficult to insert 80
Leak 72
No code available 71
Unknown (for use when the device problem is not known) 69
Entrapment of device or device component 69
Crack 68
Detachment of device component 67
Fracture 67
Device, or device fragments remain in patient 59
Fluid leak 58
Component(s), broken 58
Material rupture 53
No Known Device Problem 53
Wire(s), breakage of 50
Foreign material 43
Kinked 40
Tears, rips, holes in device, device material 37
Blockage within device or device component 34
Physical resistance 30
Detachment of device or device component 30
Device, removal of (non-implant) 28
Failure to advance 28
Use of Device Issue 25
Out-of-box failure 24
Material frayed 24
Burst 23
Migration of device or device component 23
Foreign material present in device 22
Interlumen communication 20
Fitting problem 17
Inflation issue 17
Tear, rip or hole in device packaging 15
Dislodged or dislocated 15
Occlusion within device 14
Contamination during use 14
Shaft break 13
Decoupling 12
Material perforation 11
Unsealed device packaging 11
Disconnection 11
Malfunction 11
Obstruction within device 11
Hole in material 11
Deflation issue 9
Dissection 9
Device Issue 9
Split 8
Sterility 8
Sticking 8
Device damaged prior to use 7
Device or device fragments location unknown 7
Mislabeled 7
Stretched 7
Difficult to advance 7
Component incompatible 7
Air leak 6
Source, detachment from 6
Balloon rupture 6
Material puncture 6
Improper or incorrect procedure or method 6
Device expiration issue 6
Peeled 6
Filter 5
Bent 5
Dislodged 5
Seal, defective 5
Device packaging compromised 5
Material fragmentation 5
Packaging issue 5
Torn material 5
Incompatibility problem 4
Difficult to deploy 4
Automatic injection system, incompatible 4
Needle, separation 4
Unable to obtain readings 4
Difficult to position 4
Failure to deploy 4
Component missing 4
Device-device incompatibility 4
Interference 4
Accessory incompatible 3
Catheter withdrawal interference 3
Uncoiled 3
Image display error 3
Inaccurate delivery 3
Device clogged 3
Defective item 3
Twisting 3
Device or device component damaged by another device 3
Delivered as unsterile product 3
Flaked 3
Rejection 2
Measurements, inaccurate 2
Gas leak 2
Total Device Problems 2924

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 2 0 0
Class II 1 2 2 5 4 5 0
Class III 2 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics Worldwide Headquarters II Aug-09-2012
2 Angiodynamics Worldwide Headquarters II Sep-16-2011
3 Boston Scientific II Jan-31-2008
4 Boston Scientific Corporation II Apr-11-2012
5 Boston Scientific Corporation I Jun-10-2011
6 Boston Scientific Corporation II Jan-21-2010
7 Boston Scientific Corporation II Sep-04-2009
8 Boston Scientific Corporation III Dec-06-2007
9 Boston Scientific Corporation III Aug-09-2007
10 Boston Scientific Target II Feb-01-2007
11 Cordis Corporation II Nov-17-2011
12 Edwards Lifesciences, LLC II Aug-12-2012
13 ICU Medical, Inc. II Oct-11-2012
14 ICU Medical, Inc. II Aug-02-2012
15 Merit Medical Systems, Inc. II Dec-08-2010
16 Merit Medical Systems, Inc. II May-28-2010
17 Merit Medical Systems, Inc. II Dec-14-2009
18 Merit Medical Systems, Inc. III Jan-13-2009
19 Merit Medical Systems, Inc. II Sep-04-2008
20 Millar Instruments, Inc I Mar-24-2011
21 Millar Instruments, Inc II Nov-17-2010
22 Siemens Medical Solutions USA, Inc. II Mar-23-2011
23 Vascular Solutions, Inc. II Jul-11-2011
24 Vascular Solutions, Inc. II Sep-28-2010

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