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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 8
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 363
Difficult to remove 319
Break 274
Foreign material present in device 209
Other (for use when an appropriate device code cannot be identified) 161
Unraveled material 135
No Known Device Problem 131
Tip breakage 130
Delivered as unsterile product 124
Fracture 119
Detachment of device component 119
Leak 102
Retraction problem 94
Crack 93
Difficult to insert 82
Entrapment of device or device component 79
No code available 73
Component(s), broken 69
Unknown (for use when the device problem is not known) 69
Device, or device fragments remain in patient 61
Fluid leak 61
Material rupture 58
Kinked 54
Wire(s), breakage of 50
Foreign material 43
Tears, rips, holes in device, device material 37
Detachment of device or device component 37
Blockage within device or device component 36
Air leak 36
Tear, rip or hole in device packaging 34
Failure to advance 30
Physical resistance 30
Occlusion within device 29
Migration of device or device component 29
Device, removal of (non-implant) 28
Material frayed 27
Burst 26
Use of Device Issue 25
Out-of-box failure 24
Packaging issue 24
Interlumen communication 20
Inflation issue 19
Hole in material 19
Fitting problem 18
Unsealed device packaging 17
Device packaging compromised 17
Torn material 16
Dislodged or dislocated 15
Material perforation 14
Contamination during use 14
Disconnection 13
Device Issue 13
Obstruction within device 13
Shaft break 13
Unintended movement 13
Split 12
Decoupling 12
Deflation issue 11
Malfunction 11
Stretched 11
Material puncture 10
Device damaged prior to use 10
No Information 10
Difficult to advance 10
Failure to align 10
Dissection 9
Material fragmentation 8
Sterility 8
Sticking 8
Improper or incorrect procedure or method 7
Mislabeled 7
Component incompatible 7
Balloon rupture 7
Device or device fragments location unknown 7
Device operates differently than expected 7
Device expiration issue 6
Source, detachment from 6
Peeled 6
Difficult to position 5
Unable to obtain readings 5
Seal, defective 5
Dislodged 5
Failure to deploy 5
Bent 5
Filter 5
Device-device incompatibility 5
Device or device component damaged by another device 4
Incompatibility problem 4
Defective item 4
Connection issue 4
Deployment issue 4
Interference 4
Needle, separation 4
Automatic injection system, incompatible 4
Device clogged 4
Difficult to deploy 4
Component missing 4
Incorrect or inadequate result 4
Shipping damage or problem 3
Failure to sterilize 3
Total Device Problems 4052

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