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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 35
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 572
Premature deployment 524
Failure to deploy 514
No Known Device Problem 429
Difficult to remove 399
Migration of device or device component 385
Material rupture 343
Dislodged or dislocated 316
Occlusion within device 284
Other (for use when an appropriate device code cannot be identified) 271
Difficult to deploy 271
Detachment of device component 267
Use of Device Issue 266
Dislodged 265
Fracture 264
Detachment of device or device component 240
Kinked 204
Device damaged prior to use 204
Stretched 204
Device remains implanted 193
Deployment issue 190
Failure to advance 178
Balloon burst 176
Unknown (for use when the device problem is not known) 175
No code available 153
Burst 144
Bent 142
Balloon rupture 137
Blockage within device or device component 104
Difficult to position 101
Inflation issue 97
Material deformation 92
Inaccurate delivery 90
Explanted 88
Physical resistance 82
Source, detachment from 81
Material separation 78
Positioning Issue 68
Torn material 67
Deflation issue 64
Component(s), broken 61
Retraction problem 61
Difficult to insert 60
Device, or device fragments remain in patient 59
Size incorrect for patient 53
Entrapment of device or device component 47
Shaft break 46
Hole in material 40
Foreign material present in device 40
Tears, rips, holes in device, device material 39
Leak 36
Improper or incorrect procedure or method 33
Difficult to advance 32
Sticking 28
Handpiece detachment 26
Material perforation 25
Fitting problem 24
Obstruction within device 24
Unintended movement 23
Calcified 23
Malposition of device 22
Loose 21
Material frayed 21
Tip breakage 21
No Information 20
Unsealed device packaging 19
Crack 19
Dissection 18
Balloon leak(s) 18
Strut fracture 18
Implant, removal of 18
Defective component 18
Material integrity issue 18
Displacement 16
Device markings issue 15
Packaging issue 14
Failure to deliver 14
Component missing 13
Mislabeled 13
Tear, rip or hole in device packaging 13
Device, removal of (non-implant) 13
Split 12
Defective item 11
Foreign material 11
Twisting 11
Device expiration issue 10
Collapse 10
Failure to separate 10
Failure to expand 10
Not Applicable 9
Device operates differently than expected 9
Balloon pinhole 9
Interference 9
Device Difficult to Setup or Prepare 9
User used incorrect product for intended use 9
Resistance, inadequate 9
Incorrect or inadequate result 8
Slippage of device or device component 8
Device Issue 8
Delivery system failure 8
Total Device Problems 10044

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