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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 3
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 15
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 11
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 4
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 8
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 9
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 12
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 754
Leak 605
No Known Device Problem 403
Break 366
Detachment of device component 167
Other (for use when an appropriate device code cannot be identified) 140
Difficult to remove 93
Fracture 90
Unraveled material 79
Kinked 73
Use of Device Issue 68
Fluid leak 61
Material frayed 60
Blockage within device or device component 51
Difficult to insert 50
Detachment of device or device component 47
Disconnection 43
Crack 40
Physical resistance 38
Occlusion within device 37
Air leak 34
Material fragmentation 30
Torn material 30
Difficult to advance 29
Connection issue 27
Device, or device fragments remain in patient 24
Component(s), broken 23
Unknown (for use when the device problem is not known) 23
Tip breakage 23
Tears, rips, holes in device, device material 21
Decoupling 21
Material deformation 21
No Information 21
No code available 20
Foreign material present in device 20
Stretched 19
Material perforation 18
Bent 18
Reaction 17
Hole in material 17
Device operates differently than expected 16
Split 16
Device, removal of (non-implant) 16
Material integrity issue 16
Scratched material 15
Deployment issue 15
Packaging issue 14
Positioning Issue 14
Dislodged or dislocated 14
Failure to advance 13
Fitting problem 13
Material rupture 13
Device Issue 12
Unsealed device packaging 12
Contamination during use 12
Bleed back 10
Failure to deploy 9
Wire(s), breakage of 9
Device-device incompatibility 9
Dull 8
Device markings issue 8
Improper or incorrect procedure or method 8
Flaked 8
Delivered as unsterile product 8
Migration of device or device component 8
Peeled 8
Entrapment of device or device component 7
Source, detachment from 7
Buckled material 7
Device or device fragments location unknown 7
Difficult to position 6
Dislodged 5
Human-Device Interface Issue 5
Device damaged prior to use 5
Defective component 4
Device or device component damaged by another device 4
Aspiration issue 4
Delamination 4
Dent in material 4
Dissection 4
Difficult to deploy 4
Knotted 4
Mechanical issue 4
Foreign material 3
Device remains implanted 3
Product quality issue 3
Component incompatible 3
Tear, rip or hole in device packaging 3
Device packaging compromised 3
Improper flow or infusion 3
Component missing 3
Uncoiled 3
Sterility 3
Sticking 3
Slippage of device or device component 3
Retraction problem 3
Device handling issue 3
Not Applicable 2
Temperature issue 2
Infusion or flow issue 2
Total Device Problems 4158

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 2 5 2 0 2 0 2 0 2
Class II 4 5 5 3 4 3 8 6 3 9 5
Class III 0 0 0 0 0 1 0 0 0 1 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 Angiodynamics, Inc. II Dec-16-2016
5 Angiodynamics, Inc. III Dec-16-2016
6 Argon Medical Devices, Inc II Oct-07-2016
7 Arrow International Inc II Jun-12-2017
8 Arrow International Inc II Mar-07-2016
9 Arrow International Inc II Jun-26-2015
10 Arrow International Inc II Jun-04-2014
11 Arrow International Inc II Dec-09-2013
12 Arrow International Inc II Jan-21-2011
13 Arrow International Inc II Sep-25-2010
14 Arrow International Inc I Mar-05-2010
15 Arrow International Inc II Jun-24-2009
16 Arstasis, Inc I Feb-04-2011
17 B. Braun Medical, Inc. II Dec-21-2013
18 BARD PERIPHERAL VASCULAR, INC I Jan-18-2017
19 Bard Access Systems II Mar-06-2013
20 Baylis Medical Corp * I Nov-01-2013
21 Baylis Medical Corp * I Mar-10-2010
22 Biocardia, Inc. II Mar-27-2014
23 Biocardia, Inc. II Feb-19-2014
24 Biosense Webster, Inc. II Feb-28-2007
25 Boston Scientific Corp II Apr-09-2009
26 Boston Scientific Corp II Dec-07-2007
27 Boston Scientific Corporation I Dec-18-2015
28 C. R.Bard, Inc./BardElectrophysiology Division II Nov-07-2008
29 Cook Inc. II Mar-02-2017
30 Cook Inc. II Aug-22-2016
31 Cook Inc. II Feb-24-2016
32 Cook Inc. II Jul-18-2015
33 Cook, Inc. II Apr-16-2008
34 Cordis Corporation II Apr-20-2010
35 Cordis Corporation I Nov-05-2009
36 Creganna Medical Devices II Jun-14-2017
37 Edwards Lifesciences, Llc II Aug-25-2009
38 Endologix Inc I Jun-07-2013
39 Galt Medical Corporation II Sep-04-2014
40 Greatbatch Medical II Nov-18-2016
41 Greatbatch Medical II May-13-2014
42 Greatbatch Medical II Jun-27-2013
43 Greatbatch Medical II Dec-22-2012
44 Greatbatch Medical II Oct-24-2012
45 Greatbatch Medical II Aug-27-2010
46 Medical Components, Inc dba MedComp II Jun-07-2016
47 Medtronic Inc. Cardiac Rhythm Disease Management I Mar-17-2015
48 Medtronic Inc. Cardiac Rhythm Disease Management II Aug-05-2013
49 Medtronic, Inc. II Dec-02-2008
50 Merit Medical Systems, Inc. I Mar-24-2017
51 Merit Medical Systems, Inc. II Jan-05-2017
52 Merit Medical Systems, Inc. I Jan-28-2011
53 Merit Medical Systems, Inc. II Dec-14-2009
54 Merit Medical Systems, Inc. II Jun-10-2009
55 Oscor, Inc. II Dec-19-2016
56 Oscor, Inc. II Oct-29-2008
57 Smiths Medical ASD, Inc. II Sep-23-2013
58 St Jude Medical II Oct-22-2014
59 St Jude Medical Inc III Dec-28-2012
60 St. Jude Medical / Daig Division II Mar-01-2007
61 St. Jude Medical Cardiovascular Division I Aug-12-2010
62 Stryker Instruments Div. of Stryker Corporation II Dec-14-2015
63 Terumo Medical Corporation II May-04-2017
64 Terumo Medical Corporation II Sep-06-2016
65 Terumo Medical Corporation II Jun-27-2013
66 Terumo Medical Corporation II Jun-06-2011
67 Thomas Medical Products Inc II Jan-11-2012
68 Thomas Medical Products Inc II Feb-14-2011
69 Thomas Medical Products Inc I Mar-04-2010
70 Thomas Medical Products Inc I Feb-02-2010
71 Thomas Medical Products Inc I Nov-24-2009
72 Thomas Medical Products Inc II Nov-03-2008

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