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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 9
ANGIOMETRX INC.
  SUBSTANTIALLY EQUIVALENT 2
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 2
ASAHI
  SUBSTANTIALLY EQUIVALENT 1
ASHITAKA FACTORY OF TERUMO CORP.
  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 39
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 16
COBE INC.
  SUBSTANTIALLY EQUIVALENT 1
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 6
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 6
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.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 2
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
  SUBSTANTIALLY EQUIVALENT - KIT 1
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6
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
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD
  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
Material separation 369
Difficult to remove 324
Break 276
Foreign material present in device 245
Other (for use when an appropriate device code cannot be identified) 161
No Known Device Problem 145
Unraveled material 135
Tip breakage 130
Fracture 129
Detachment of device component 129
Delivered as unsterile product 124
Leak 102
Retraction problem 101
Crack 95
Difficult to insert 82
Entrapment of device or device component 80
No code available 73
Unknown (for use when the device problem is not known) 69
Component(s), broken 69
Fluid leak 61
Device, or device fragments remain in patient 61
Material rupture 59
Kinked 54
Wire(s), breakage of 50
Foreign material 43
Blockage within device or device component 41
Detachment of device or device component 37
Tears, rips, holes in device, device material 37
Air leak 36
Tear, rip or hole in device packaging 34
Packaging issue 31
Failure to advance 30
Physical resistance 30
Migration of device or device component 29
Occlusion within device 29
Device, removal of (non-implant) 28
Material frayed 27
Burst 26
Use of Device Issue 25
Out-of-box failure 24
Unsealed device packaging 20
Device packaging compromised 20
Interlumen communication 20
Inflation issue 19
Hole in material 19
Fitting problem 18
Unintended movement 16
Torn material 16
Device Issue 15
Dislodged or dislocated 15
Contamination during use 14
Material perforation 14
Disconnection 13
Shaft break 13
Obstruction within device 13
Decoupling 12
Split 12
Failure to align 11
Stretched 11
Malfunction 11
Material puncture 11
Deflation issue 11
Device damaged prior to use 10
Difficult to advance 10
No Information 10
Dissection 9
Material fragmentation 9
Sticking 8
Sterility 8
Device operates differently than expected 7
Improper or incorrect procedure or method 7
Balloon rupture 7
Mislabeled 7
Component incompatible 7
Device or device fragments location unknown 7
Device expiration issue 6
Source, detachment from 6
Peeled 6
Dislodged 5
Seal, defective 5
Device-device incompatibility 5
Failure to deploy 5
Difficult to position 5
Incorrect or inadequate result 5
Unable to obtain readings 5
Filter 5
Bent 5
Interference 4
Incompatibility problem 4
Automatic injection system, incompatible 4
Component missing 4
Deployment issue 4
Connection issue 4
Difficult to deploy 4
Defective item 4
Device clogged 4
Device or device component damaged by another device 4
Needle, separation 4
Accessory incompatible 3
Image display error 3
Total Device Problems 4173

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 2 0 0 1 1 3 0
Class II 1 2 2 5 4 5 2 1 0 3 0
Class III 2 0 1 0 0 0 0 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 Arrow International Inc II Nov-02-2016
4 B. Braun Medical, Inc. II May-20-2016
5 Boston Scientific II Jan-31-2008
6 Boston Scientific Corporation II Apr-11-2012
7 Boston Scientific Corporation I Jun-10-2011
8 Boston Scientific Corporation II Jan-21-2010
9 Boston Scientific Corporation II Sep-04-2009
10 Boston Scientific Corporation III Dec-06-2007
11 Boston Scientific Corporation III Aug-09-2007
12 Boston Scientific Target II Feb-01-2007
13 Cook Inc. II Aug-22-2016
14 Cook Inc. I Feb-24-2016
15 Cook Inc. I Aug-05-2015
16 Cordis Corporation II Nov-17-2011
17 Edwards Lifesciences, LLC II Aug-12-2012
18 ICU Medical, Inc. II Oct-11-2012
19 ICU Medical, Inc. II Aug-02-2012
20 Merit Medical Systems, Inc. II Oct-22-2013
21 Merit Medical Systems, Inc. II May-25-2013
22 Merit Medical Systems, Inc. II Dec-08-2010
23 Merit Medical Systems, Inc. II May-28-2010
24 Merit Medical Systems, Inc. II Dec-14-2009
25 Merit Medical Systems, Inc. III Jan-13-2009
26 Merit Medical Systems, Inc. II Sep-04-2008
27 Millar Instruments, Inc I Mar-24-2011
28 Millar Instruments, Inc II Nov-17-2010
29 Siemens Medical Solutions USA, Inc. II Mar-23-2011
30 Stryker Sustainability Solutions I Jul-22-2016
31 Vascular Solutions, Inc. I Oct-20-2016
32 Vascular Solutions, Inc. I Jul-03-2014
33 Vascular Solutions, Inc. II Jul-11-2011
34 Vascular Solutions, Inc. II Sep-28-2010
35 Volcano Corporation II Sep-12-2014

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