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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device introducer, catheter
Regulation Description Catheter introducer.
Product CodeDYB
Regulation Number 870.1340
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ACUMEN, INC.
  SUBSTANTIALLY EQUIVALENT 9
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
ANGEION CORP.
  SUBSTANTIALLY EQUIVALENT 3
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 4
ARGON MEDICAL DEVICES INC.
  SUBSTANTIALLY EQUIVALENT 2
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 11
ARSTASIS, INC.
  SUBSTANTIALLY EQUIVALENT 12
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 9
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 2
BD
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 1
BIPORE, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 10
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 13
CONTRACT MANUFACTURER
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 11
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 19
CREGANNA MEDICAL DEVICES
  SUBSTANTIALLY EQUIVALENT 1
CRYOCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 5
DIAG CORP.
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 10
ENDOLOGIX, INC.
  SUBSTANTIALLY EQUIVALENT 3
ENPATH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
EP MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FOOTPRINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 3
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 2
GUIDED DELIVERY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 2
HEARTPORT, INC.
  SUBSTANTIALLY EQUIVALENT 1
HORIZON MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
INTERMEDICS
  SUBSTANTIALLY EQUIVALENT 1
JOHNSON & JOHNSON
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 3
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 2
MARTECH MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 3
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEADOX
  SUBSTANTIALLY EQUIVALENT 1
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 4
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 8
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 11
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICROVENA
  SUBSTANTIALLY EQUIVALENT 1
MICRUS
  SUBSTANTIALLY EQUIVALENT 1
NMT CORP.
  SUBSTANTIALLY EQUIVALENT 1
NOVOSTE CORP
  SUBSTANTIALLY EQUIVALENT 1
OHMEDA MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 12
PACE MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
PAJUNK GMBH
  SUBSTANTIALLY EQUIVALENT 1
Remington Medical, Inc.
  SUBSTANTIALLY EQUIVALENT 1
SCHNEIDER/NAMIC
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
SMITHS
  SUBSTANTIALLY EQUIVALENT 1
SPECIALIZED HEALTH PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 46
TELECTRONICS
  SUBSTANTIALLY EQUIVALENT 1
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 8
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 22
TFX MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
THOMAS MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 17
THORATEC CORP.
  SUBSTANTIALLY EQUIVALENT 1
TOGO MEDIKIT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 3
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 3
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 2
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 7

Device Problems
Material separation 507
Leak 499
Break 276
No Known Device Problem 276
Detachment of device component 142
Other (for use when an appropriate device code cannot be identified) 139
Difficult to remove 70
Use of Device Issue 62
Fracture 59
Unraveled material 54
Fluid leak 47
Kinked 46
Difficult to insert 41
Disconnection 41
Material frayed 39
Crack 32
Air leak 29
Blockage within device or device component 27
Detachment of device or device component 26
Physical resistance 24
Device, or device fragments remain in patient 23
Unknown (for use when the device problem is not known) 23
Component(s), broken 23
Torn material 22
Tip breakage 22
Decoupling 21
Tears, rips, holes in device, device material 21
No Information 19
Difficult to advance 18
Deployment issue 18
Reaction 17
Material deformation 17
Device, removal of (non-implant) 16
Material perforation 16
Occlusion within device 15
No code available 13
Packaging issue 13
Fitting problem 13
Failure to deploy 12
Hole in material 12
Stretched 12
Material rupture 12
Scratched material 12
Contamination during use 12
Foreign material present in device 11
Unsealed device packaging 10
Bent 10
Device operates differently than expected 9
Wire(s), breakage of 9
Material fragmentation 9
Device-device incompatibility 9
Device Issue 8
Dull 8
Split 8
Failure to advance 8
Material integrity issue 8
Improper or incorrect procedure or method 7
Source, detachment from 7
Migration of device or device component 6
Delivered as unsterile product 6
Human-Device Interface Issue 5
Device or device fragments location unknown 5
Dislodged 5
Dissection 4
Difficult to position 3
Improper flow or infusion 3
Device markings issue 3
Knotted 3
Component incompatible 3
Device remains implanted 3
Device or device component damaged by another device 3
Sterility 3
Foreign material 3
Defective component 3
Tear, rip or hole in device packaging 3
Product quality issue 3
Bleed back 3
Difficult to deploy 3
Dislodged or dislocated 3
Retraction problem 3
Delamination 3
Not Applicable 2
Explanted 2
Melted 2
Particulates 2
Connection issue 2
Valve(s), defective 2
Patient-device incompatibility 2
Uncoiled 2
Inflation issue 2
Infusion or flow issue 2
Device handling issue 2
Material rigid or stiff 2
Incomplete or missing packaging 2
Dent in material 2
Valve(s), failure of 2
Size incorrect for patient 2
Positioning Issue 2
Device damaged prior to use 2
Entrapment of device or device component 2
Total Device Problems 3079

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 2 5 2 0 2 0 2 0
Class II 4 5 5 3 4 3 8 6 3 2
Class III 0 0 0 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular, Inc. II Mar-08-2007
2 Access Scientific Inc II Sep-18-2013
3 Angiodynamics, INC II Oct-13-2011
4 Arrow International Inc II Mar-07-2016
5 Arrow International Inc II Jun-26-2015
6 Arrow International Inc II Jun-04-2014
7 Arrow International Inc II Dec-09-2013
8 Arrow International Inc II Jan-21-2011
9 Arrow International Inc II Sep-25-2010
10 Arrow International Inc I Mar-05-2010
11 Arrow International Inc II Jun-24-2009
12 Arstasis, Inc I Feb-04-2011
13 B. Braun Medical, Inc. II Dec-21-2013
14 Bard Access Systems II Mar-06-2013
15 Baylis Medical Corp * I Nov-01-2013
16 Baylis Medical Corp * I Mar-10-2010
17 Biocardia, Inc. II Mar-27-2014
18 Biocardia, Inc. II Feb-19-2014
19 Biosense Webster, Inc. II Feb-28-2007
20 Boston Scientific Corp II Apr-09-2009
21 Boston Scientific Corp II Dec-07-2007
22 Boston Scientific Corporation I Dec-18-2015
23 C. R.Bard, Inc./BardElectrophysiology Division II Nov-07-2008
24 Cook Inc. II Feb-24-2016
25 Cook Inc. II Jul-18-2015
26 Cook, Inc. II Apr-16-2008
27 Cordis Corporation II Apr-20-2010
28 Cordis Corporation I Nov-05-2009
29 Edwards Lifesciences, Llc II Aug-25-2009
30 Endologix Inc I Jun-07-2013
31 Galt Medical Corporation II Sep-04-2014
32 Greatbatch Medical II May-13-2014
33 Greatbatch Medical II Jun-27-2013
34 Greatbatch Medical II Dec-22-2012
35 Greatbatch Medical II Oct-24-2012
36 Greatbatch Medical II Aug-27-2010
37 Medtronic Inc. Cardiac Rhythm Disease Management I Mar-17-2015
38 Medtronic Inc. Cardiac Rhythm Disease Management II Aug-05-2013
39 Medtronic, Inc. II Dec-02-2008
40 Merit Medical Systems, Inc. I Jan-28-2011
41 Merit Medical Systems, Inc. II Dec-14-2009
42 Merit Medical Systems, Inc. II Jun-10-2009
43 Oscor, Inc. II Oct-29-2008
44 Smiths Medical ASD, Inc. II Sep-23-2013
45 St Jude Medical II Oct-22-2014
46 St Jude Medical Inc III Dec-28-2012
47 St. Jude Medical / Daig Division II Mar-01-2007
48 St. Jude Medical Cardiovascular Division I Aug-12-2010
49 Stryker Instruments Div. of Stryker Corporation II Dec-14-2015
50 Terumo Medical Corporation II Jun-27-2013
51 Terumo Medical Corporation II Jun-06-2011
52 Thomas Medical Products Inc II Jan-11-2012
53 Thomas Medical Products Inc II Feb-14-2011
54 Thomas Medical Products Inc I Mar-04-2010
55 Thomas Medical Products Inc I Feb-02-2010
56 Thomas Medical Products Inc I Nov-24-2009
57 Thomas Medical Products Inc II Nov-03-2008

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