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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, biliary, diagnostic
Regulation Description Biliary catheter and accessories.
Product CodeFGE
Regulation Number 876.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
  SE - WITH LIMITATIONS 9
ADVANCED CARDIOVASCULAR SYSTEMS
  SE - WITH LIMITATIONS 2
ANGIODYNAMICS, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 3
ANGIOTECH
  SUBSTANTIALLY EQUIVALENT 2
AOMORI OLYMPUS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
AVANTEC VASCULAR CORP.
  SE - WITH LIMITATIONS 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SE - WITH LIMITATIONS 20
  SUBSTANTIALLY EQUIVALENT 36
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 8
  SE - WITH LIMITATIONS 10
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SE - WITH LIMITATIONS 8
  SUBSTANTIALLY EQUIVALENT 13
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 5
  SE - WITH LIMITATIONS 35
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
  SE - WITH LIMITATIONS 5
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
  SE - WITH LIMITATIONS 10
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
GI SUPPLY
  SUBSTANTIALLY EQUIVALENT 1
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 2
  SE - WITH LIMITATIONS 19
IDEV TECHNOLOGIES, INC.
  SE - WITH LIMITATIONS 7
INTERNATIONAL MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
LUCAS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEADOX
  SUBSTANTIALLY EQUIVALENT 3
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 4
MEDINOL LTD.
  SUBSTANTIALLY EQUIVALENT 1
  SE - WITH LIMITATIONS 3
MEDTRONIC, INC.
  SE - WITH LIMITATIONS 12
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 4
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 4
ORBUS MEDICAL TECHNOLOGIES
  SE - WITH LIMITATIONS 8
PRIMROSE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SOLOS ENDOSCOPY, INC
  SUBSTANTIALLY EQUIVALENT 1
SPECIALTY SURGICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
SULZER
  SUBSTANTIALLY EQUIVALENT 1
  SE - WITH LIMITATIONS 6
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SE - WITH LIMITATIONS 2
WILSON COOK MEDICAL
  SE - WITH LIMITATIONS 2
  SUBSTANTIALLY EQUIVALENT 16

Device Problems
Break 628
Premature deployment 531
Failure to deploy 518
No Known Device Problem 474
Material rupture 444
Difficult to remove 427
Migration of device or device component 408
Dislodged or dislocated 346
Occlusion within device 293
Difficult to deploy 281
Detachment of device component 278
Fracture 272
Other (for use when an appropriate device code cannot be identified) 271
Use of Device Issue 270
Dislodged 265
Detachment of device or device component 256
Deployment issue 226
Kinked 225
Device damaged prior to use 207
Stretched 204
Device remains implanted 193
Failure to advance 181
Balloon burst 176
Unknown (for use when the device problem is not known) 175
No code available 155
Bent 151
Burst 145
Balloon rupture 137
Blockage within device or device component 120
Material deformation 117
Difficult to position 101
Inflation issue 99
Inaccurate delivery 92
Material separation 89
Explanted 88
Physical resistance 83
Source, detachment from 81
Positioning Issue 74
Deflation issue 69
Torn material 67
Component(s), broken 61
Difficult to insert 61
Retraction problem 61
Device, or device fragments remain in patient 59
Entrapment of device or device component 55
Size incorrect for patient 53
Leak 48
Hole in material 48
Shaft break 46
Foreign material present in device 41
Tears, rips, holes in device, device material 39
Improper or incorrect procedure or method 34
Difficult to advance 34
Sticking 29
Calcified 27
Handpiece detachment 26
Material perforation 25
Fitting problem 24
Obstruction within device 24
Defective component 23
Unintended movement 23
Malposition of device 23
Loose 21
Tip breakage 21
Material frayed 21
No Information 20
Crack 20
Unsealed device packaging 19
Balloon leak(s) 18
Implant, removal of 18
Split 18
Dissection 18
Strut fracture 18
Material integrity issue 18
Displacement 16
Device markings issue 15
User used incorrect product for intended use 15
Tear, rip or hole in device packaging 15
Failure to deliver 14
Packaging issue 14
Device, removal of (non-implant) 13
Mislabeled 13
Component missing 13
Twisting 11
Foreign material 11
Failure to separate 11
Defective item 11
Device expiration issue 10
Collapse 10
Failure to expand 10
Device Difficult to Setup or Prepare 9
Not Applicable 9
Interference 9
Device operates differently than expected 9
Balloon pinhole 9
Device packaging compromised 9
Resistance, inadequate 9
Device Issue 8
Delivery system failure 8
Slippage of device or device component 8
Total Device Problems 10600

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 3 8 7 8 1 5 3 1 3 0 0
Class III 1 1 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II Sep-25-2012
2 Bard Peripheral Vascular Inc II Jun-17-2009
3 Bard Peripheral Vascular Inc II Oct-10-2008
4 Boston Scientific Corp III Sep-11-2008
5 Boston Scientific Corporation II Jul-01-2015
6 Boston Scientific Corporation II Mar-31-2015
7 Boston Scientific Corporation II Mar-27-2015
8 Boston Scientific Corporation II Jan-10-2014
9 Boston Scientific Corporation II Aug-25-2010
10 Boston Scientific Corporation II Mar-25-2010
11 Boston Scientific Corporation II Nov-13-2009
12 Boston Scientific Corporation II Aug-27-2009
13 Boston Scientific Corporation II May-21-2009
14 Boston Scientific Corporation II Mar-13-2007
15 Conmed Endoscopic Technologies, Inc. II Apr-11-2007
16 Cook Endoscopy II Jan-19-2011
17 Cook Endoscopy II Oct-14-2008
18 Cook Endoscopy II Sep-23-2008
19 Cordis Corporation II Jun-06-2013
20 Cordis Corporation II May-10-2012
21 Cordis Corporation II Feb-15-2012
22 Edwards Lifesciences, Llc II Jul-02-2008
23 Edwards Lifesciences, Llc II Nov-28-2007
24 Ev3, Inc II Sep-26-2008
25 Ev3, Inc II Aug-26-2008
26 Ev3, Inc II Aug-26-2008
27 Ev3, Inc II May-06-2008
28 Ev3, Inc III Feb-01-2007
29 Ev3, Inc. II Dec-16-2010
30 Ev3, Inc. II May-13-2010
31 Ev3, Inc. II Dec-01-2009
32 Ev3, Inc. II Sep-08-2009
33 IDEV Technologies, Inc. II Jun-18-2013
34 Idev Technologies, Inc. II Mar-15-2012
35 Medtronic CardioVascular II Jun-14-2010
36 Medtronic CardioVascular II Jan-19-2010
37 Medtronic Cardiovascular III Mar-18-2009
38 Merit Medical Systems, Inc. II Feb-20-2013
39 Merit Medical Systems, Inc. II Feb-22-2010
40 Merit Medical Systems, Inc. II Jan-13-2009
41 Navilyst Medical, Inc II Jan-11-2012
42 Navilyst Medical, Inc II Oct-07-2010

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