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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 14
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 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 561
Leak 534
No Known Device Problem 320
Break 307
Detachment of device component 149
Other (for use when an appropriate device code cannot be identified) 139
Difficult to remove 77
Fracture 71
Use of Device Issue 62
Unraveled material 61
Kinked 58
Fluid leak 48
Difficult to insert 43
Material frayed 41
Disconnection 41
Detachment of device or device component 33
Physical resistance 32
Crack 32
Air leak 30
Blockage within device or device component 27
Torn material 25
Difficult to advance 24
Unknown (for use when the device problem is not known) 23
Device, or device fragments remain in patient 23
Component(s), broken 23
Tip breakage 22
Tears, rips, holes in device, device material 21
Decoupling 21
No Information 21
Material deformation 18
Deployment issue 18
Material perforation 17
Reaction 17
Material fragmentation 16
Device, removal of (non-implant) 16
Stretched 15
Occlusion within device 15
No code available 14
Packaging issue 13
Fitting problem 13
Foreign material present in device 13
Dislodged or dislocated 12
Material rupture 12
Hole in material 12
Failure to deploy 12
Contamination during use 12
Scratched material 12
Bent 11
Unsealed device packaging 11
Device operates differently than expected 11
Split 11
Material integrity issue 10
Wire(s), breakage of 9
Failure to advance 9
Device-device incompatibility 9
Device Issue 8
Improper or incorrect procedure or method 8
Dull 8
Migration of device or device component 8
Delivered as unsterile product 7
Source, detachment from 7
Device markings issue 7
Device or device fragments location unknown 6
Human-Device Interface Issue 5
Dislodged 5
Dissection 4
Entrapment of device or device component 4
Dent in material 4
Defective component 4
Sterility 3
Tear, rip or hole in device packaging 3
Improper flow or infusion 3
Delamination 3
Device or device component damaged by another device 3
Bleed back 3
Difficult to deploy 3
Component incompatible 3
Product quality issue 3
Device remains implanted 3
Difficult to position 3
Retraction problem 3
Inflation issue 3
Foreign material 3
Knotted 3
Positioning Issue 3
Device handling issue 3
Not Applicable 2
Temperature issue 2
Failure to pace or properly pace 2
Mechanical issue 2
Melted 2
Material rigid or stiff 2
Material puncture 2
Particulates 2
Peeled 2
Electrode(s), migration of 2
Explanted 2
Connection issue 2
Infusion or flow issue 2
Defective item 2
Total Device Problems 3371

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

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