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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 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 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 602
Leak 548
No Known Device Problem 339
Break 330
Detachment of device component 153
Other (for use when an appropriate device code cannot be identified) 140
Difficult to remove 82
Fracture 77
Use of Device Issue 65
Unraveled material 64
Kinked 64
Fluid leak 53
Blockage within device or device component 51
Difficult to insert 45
Material frayed 42
Disconnection 42
Occlusion within device 37
Detachment of device or device component 37
Physical resistance 36
Crack 33
Air leak 30
Difficult to advance 25
Torn material 25
Unknown (for use when the device problem is not known) 23
Tip breakage 23
Device, or device fragments remain in patient 23
Component(s), broken 23
Decoupling 21
Tears, rips, holes in device, device material 21
No Information 21
Material fragmentation 20
Material deformation 19
Material perforation 18
Deployment issue 18
Bent 17
Reaction 17
Connection issue 16
Device, removal of (non-implant) 16
No code available 16
Foreign material present in device 15
Stretched 15
Split 14
Packaging issue 14
Fitting problem 13
Dislodged or dislocated 12
Device operates differently than expected 12
Material rupture 12
Unsealed device packaging 12
Hole in material 12
Contamination during use 12
Failure to deploy 12
Scratched material 12
Material integrity issue 12
Device-device incompatibility 9
Wire(s), breakage of 9
Device Issue 9
Failure to advance 9
Device markings issue 8
Improper or incorrect procedure or method 8
Dull 8
Bleed back 8
Migration of device or device component 8
Delivered as unsterile product 8
Source, detachment from 7
Device or device fragments location unknown 7
Human-Device Interface Issue 5
Dislodged 5
Dissection 4
Entrapment of device or device component 4
Device or device component damaged by another device 4
Dent in material 4
Defective component 4
Sterility 3
Sticking 3
Uncoiled 3
Tear, rip or hole in device packaging 3
Delamination 3
Improper flow or infusion 3
Difficult to deploy 3
Component incompatible 3
Product quality issue 3
Device remains implanted 3
Difficult to position 3
Retraction problem 3
Mechanical issue 3
Inflation issue 3
Foreign material 3
Knotted 3
Positioning Issue 3
Device handling issue 3
Not Applicable 2
Temperature issue 2
Melted 2
Misconnection 2
Failure to pace or properly pace 2
Material rigid or stiff 2
Material puncture 2
Particulates 2
Peeled 2
Electrode(s), migration of 2
Total Device Problems 3613

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

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