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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 4
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 2
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 15
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 2
  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
NUMED, INC.
  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 23
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 853
Leak 665
No Known Device Problem 489
Break 403
Detachment of device component 211
Other (for use when an appropriate device code cannot be identified) 140
Difficult to remove 101
Fracture 99
Fluid leak 88
Unraveled material 87
Kinked 86
Material frayed 75
Use of Device Issue 75
Detachment of device or device component 60
Difficult to insert 60
Air leak 55
Blockage within device or device component 51
Crack 45
Disconnection 43
Occlusion within device 40
Physical resistance 40
Torn material 39
Material fragmentation 38
Connection issue 33
Material deformation 33
Difficult to advance 31
Foreign material present in device 27
Device operates differently than expected 25
Stretched 24
Device, or device fragments remain in patient 24
Tip breakage 23
Unknown (for use when the device problem is not known) 23
Component(s), broken 23
Split 22
Tears, rips, holes in device, device material 21
Decoupling 21
Hole in material 21
No Information 21
No code available 21
Bent 20
Material perforation 19
Material integrity issue 18
Reaction 17
Material rupture 16
Device, removal of (non-implant) 16
Deployment issue 15
Failure to advance 15
Fitting problem 15
Scratched material 15
Packaging issue 15
Positioning Issue 14
Dislodged or dislocated 14
Unsealed device packaging 13
Bleed back 12
Contamination during use 12
Device Issue 12
Buckled material 12
Device markings issue 9
Patient-device incompatibility 9
Wire(s), breakage of 9
Improper or incorrect procedure or method 9
Device damaged prior to use 9
Failure to deploy 9
Delivered as unsterile product 9
Migration of device or device component 9
Device-device incompatibility 9
Peeled 8
Entrapment of device or device component 8
Flaked 8
Dull 8
Device or device fragments location unknown 8
Source, detachment from 7
Difficult to position 7
Knotted 7
Device or device component damaged by another device 7
Device packaging compromised 6
Human-Device Interface Issue 6
Dislodged 5
Defective item 5
Tear, rip or hole in device packaging 5
Dent in material 4
Aspiration issue 4
Wrinkled 4
Delamination 4
Defective component 4
Sticking 4
Uncoiled 4
Dissection 4
Difficult to deploy 4
Mechanical issue 4
Device handling issue 4
Improper flow or infusion 3
Material puncture 3
Product quality issue 3
Foreign material 3
Component incompatible 3
Sterility 3
Slippage of device or device component 3
Retraction problem 3
Material rigid or stiff 3
Total Device Problems 4753

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

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