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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 10
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 7
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 1
  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 403
Difficult to remove 348
Foreign material present in device 315
Break 280
No Known Device Problem 185
Other (for use when an appropriate device code cannot be identified) 160
Detachment of device component 154
Fracture 153
Unraveled material 135
Tip breakage 130
Delivered as unsterile product 126
Retraction problem 119
Leak 103
Crack 98
Entrapment of device or device component 86
Difficult to insert 82
No code available 72
Component(s), broken 69
Unknown (for use when the device problem is not known) 69
Fluid leak 62
Device, or device fragments remain in patient 61
Material rupture 59
Kinked 54
Wire(s), breakage of 50
Unsealed device packaging 45
Foreign material 43
Blockage within device or device component 41
Tear, rip or hole in device packaging 40
Air leak 39
Detachment of device or device component 38
Tears, rips, holes in device, device material 37
Occlusion within device 34
Migration of device or device component 34
Packaging issue 34
Physical resistance 31
Failure to advance 30
Device, removal of (non-implant) 28
Burst 28
Material frayed 27
Use of Device Issue 25
Out-of-box failure 24
Device packaging compromised 22
Unintended movement 22
Interlumen communication 20
Inflation issue 19
Hole in material 19
Fitting problem 18
Torn material 16
Dislodged or dislocated 15
Failure to align 15
Device Issue 15
Material perforation 15
Obstruction within device 14
Contamination during use 14
Disconnection 13
Material puncture 13
Shaft break 13
Difficult to advance 13
Split 12
Decoupling 12
Deflation issue 12
Stretched 11
Malfunction 11
Device damaged prior to use 11
No Information 11
Material fragmentation 10
Dissection 9
Device operates differently than expected 9
Sticking 8
Sterility 8
Improper or incorrect procedure or method 7
Component incompatible 7
Balloon rupture 7
Mislabeled 7
Device or device fragments location unknown 7
Device-device incompatibility 6
Device expiration issue 6
Source, detachment from 6
Peeled 6
Incorrect or inadequate result 6
Unable to obtain readings 5
Difficult to position 5
Seal, defective 5
Filter 5
Bent 5
Dislodged 5
Failure to deploy 5
Difficult to deploy 4
Automatic injection system, incompatible 4
Device clogged 4
Interference 4
Needle, separation 4
Incompatibility problem 4
Defective item 4
Component missing 4
Connection issue 4
Device or device component damaged by another device 4
Deployment issue 4
Device markings issue 3
Expulsion 3
Total Device Problems 4501

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

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