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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 665
Premature deployment 535
Failure to deploy 520
No Known Device Problem 507
Material rupture 491
Difficult to remove 439
Migration of device or device component 414
Dislodged or dislocated 356
Occlusion within device 300
Difficult to deploy 289
Detachment of device component 287
Fracture 282
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 263
Deployment issue 240
Kinked 232
Device damaged prior to use 209
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 130
Material deformation 126
Difficult to position 102
Inflation issue 99
Inaccurate delivery 92
Material separation 91
Explanted 88
Physical resistance 83
Source, detachment from 81
Positioning Issue 75
Deflation issue 72
Torn material 67
Difficult to insert 62
Component(s), broken 61
Retraction problem 61
Device, or device fragments remain in patient 59
Entrapment of device or device component 59
Size incorrect for patient 53
Leak 52
Hole in material 50
Shaft break 46
Foreign material present in device 43
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
Defective component 26
Material perforation 25
Fitting problem 24
Unintended movement 24
Obstruction within device 24
Malposition of device 23
Tip breakage 21
Loose 21
Material frayed 21
Crack 20
No Information 20
Split 19
Unsealed device packaging 19
Strut fracture 18
Implant, removal of 18
Dissection 18
Balloon leak(s) 18
Tear, rip or hole in device packaging 18
Material integrity issue 18
Displacement 16
Component missing 16
User used incorrect product for intended use 16
Device markings issue 15
Packaging issue 14
Failure to deliver 14
Mislabeled 13
Device, removal of (non-implant) 13
Failure to separate 11
Defective item 11
Failure to expand 11
Device packaging compromised 11
Foreign material 11
Twisting 11
Device expiration issue 10
Collapse 10
Interference 9
Device Difficult to Setup or Prepare 9
Resistance, inadequate 9
Not Applicable 9
Balloon pinhole 9
Device operates differently than expected 9
Delivery system failure 8
Delivery System Issue, No Description 8
Incorrect or inadequate result 8
Total Device Problems 10875

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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