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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 4
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 677
Premature deployment 540
Failure to deploy 522
No Known Device Problem 515
Material rupture 514
Difficult to remove 445
Migration of device or device component 424
Dislodged or dislocated 362
Occlusion within device 300
Difficult to deploy 294
Detachment of device component 291
Fracture 289
Use of Device Issue 271
Other (for use when an appropriate device code cannot be identified) 271
Detachment of device or device component 270
Dislodged 265
Deployment issue 245
Kinked 236
Device damaged prior to use 211
Stretched 204
Device remains implanted 193
Failure to advance 184
Balloon burst 176
Unknown (for use when the device problem is not known) 175
No code available 155
Bent 151
Burst 148
Balloon rupture 137
Blockage within device or device component 132
Material deformation 132
Difficult to position 102
Inflation issue 100
Material separation 94
Inaccurate delivery 92
Explanted 88
Physical resistance 83
Source, detachment from 81
Positioning Issue 77
Deflation issue 76
Torn material 68
Difficult to insert 62
Component(s), broken 61
Retraction problem 61
Entrapment of device or device component 60
Device, or device fragments remain in patient 59
Leak 54
Size incorrect for patient 53
Hole in material 51
Shaft break 46
Foreign material present in device 43
Tears, rips, holes in device, device material 39
Difficult to advance 36
Improper or incorrect procedure or method 34
Sticking 29
Defective component 27
Calcified 27
Handpiece detachment 26
Material perforation 25
Unintended movement 25
Obstruction within device 24
Fitting problem 24
Malposition of device 23
Tip breakage 21
Loose 21
Material frayed 21
Crack 20
No Information 20
Material integrity issue 19
Tear, rip or hole in device packaging 19
Split 19
Unsealed device packaging 19
Strut fracture 18
Implant, removal of 18
Dissection 18
Balloon leak(s) 18
User used incorrect product for intended use 17
Component missing 16
Displacement 16
Device markings issue 15
Packaging issue 14
Failure to deliver 14
Mislabeled 13
Device, removal of (non-implant) 13
Failure to expand 12
Device packaging compromised 11
Failure to separate 11
Defective item 11
Foreign material 11
Twisting 11
Device Difficult to Setup or Prepare 10
Device expiration issue 10
Collapse 10
Interference 9
Resistance, inadequate 9
Balloon pinhole 9
Device operates differently than expected 9
Not Applicable 9
Delivery system failure 8
Delivery System Issue, No Description 8
Incorrect or inadequate result 8
Total Device Problems 11014

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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