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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
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 9
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 2
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 1
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.
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 2
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BIOSEARCH MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 29
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 18
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 6
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 9
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 1
CONMED
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 11
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 8
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 5
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 34
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 5
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 10
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
GI SUPPLY
  SUBSTANTIALLY EQUIVALENT 1
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 19
IDEV TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT - 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
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 12
MENTOR CORP.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 1
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
OLYMPUS
  SUBSTANTIALLY EQUIVALENT 4
ORBUS MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT - 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
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 6
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 2
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 14
  SUBSTANTIALLY EQUIVALENT - WITH LIMITATIONS 2

Device Problems
Failure to deploy 497
Premature deployment 492
Break 398
Difficult to remove 321
Migration of device or device component 296
Dislodged 265
Other (for use when an appropriate device code cannot be identified) 261
No Known Device Problem 254
Use of Device Issue 253
Occlusion within device 222
Difficult to deploy 217
Dislodged or dislocated 207
Device damaged prior to use 198
Detachment of device or device component 197
Detachment of device component 196
Stretched 196
Device remains implanted 193
Balloon burst 176
Unknown (for use when the device problem is not known) 174
Fracture 170
Failure to advance 163
No code available 140
Balloon rupture 137
Burst 127
Kinked 126
Bent 121
Difficult to position 97
Inaccurate delivery 89
Explanted 88
Inflation issue 85
Physical resistance 79
Source, detachment from 79
Deployment issue 76
Material separation 67
Component(s), broken 60
Difficult to insert 58
Retraction problem 58
Device, or device fragments remain in patient 56
Positioning Issue 55
Blockage within device or device component 55
Size incorrect for patient 49
Torn material 49
Material deformation 47
Deflation issue 45
Shaft break 45
Tears, rips, holes in device, device material 39
Leak 34
Foreign material present in device 32
Hole in material 30
Difficult to advance 29
Improper or incorrect procedure or method 29
Sticking 27
Handpiece detachment 26
Entrapment of device or device component 25
Obstruction within device 24
Fitting problem 24
Material perforation 23
Tip breakage 21
Loose 21
Balloon leak(s) 18
Strut fracture 18
Dissection 18
Crack 17
Malposition of device 17
Material integrity issue 17
Unintended movement 17
Unsealed device packaging 17
Implant, removal of 17
Displacement 16
Material rupture 15
Failure to deliver 14
Mislabeled 13
Device, removal of (non-implant) 13
No Information 13
Packaging issue 12
Tear, rip or hole in device packaging 11
Twisting 11
Split 11
Foreign material 11
Device expiration issue 10
Component missing 10
Device Difficult to Setup or Prepare 9
Balloon pinhole 9
Defective item 9
Collapse 9
Interference 9
Resistance, inadequate 9
Material frayed 8
Slippage of device or device component 8
Incorrect or inadequate result 8
Calcified 7
Cut in material 7
Not Applicable 7
Device Issue 7
Loose or intermittent connection 7
Delivery System Issue, No Description 7
Suture line separation 6
Wire(s), breakage of 6
Degraded 6
Failure to separate 6
Total Device Problems 8078

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 3 8 7 8 1 5 1
Class III 1 1 1 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 Aug-25-2010
6 Boston Scientific Corporation II Mar-25-2010
7 Boston Scientific Corporation II Nov-13-2009
8 Boston Scientific Corporation II Aug-27-2009
9 Boston Scientific Corporation II May-21-2009
10 Boston Scientific Corporation II Mar-13-2007
11 Conmed Endoscopic Technologies, Inc. II Apr-11-2007
12 Cook Endoscopy II Jan-19-2011
13 Cook Endoscopy II Oct-14-2008
14 Cook Endoscopy II Sep-23-2008
15 Cordis Corporation II May-10-2012
16 Cordis Corporation II Feb-15-2012
17 Edwards Lifesciences, Llc II Jul-02-2008
18 Edwards Lifesciences, Llc II Nov-28-2007
19 Ev3, Inc II Sep-26-2008
20 Ev3, Inc II Aug-26-2008
21 Ev3, Inc II Aug-26-2008
22 Ev3, Inc II May-06-2008
23 Ev3, Inc III Feb-01-2007
24 Ev3, Inc. II Dec-16-2010
25 Ev3, Inc. II May-13-2010
26 Ev3, Inc. II Dec-01-2009
27 Ev3, Inc. II Sep-08-2009
28 Idev Technologies, Inc. II Mar-15-2012
29 Medtronic CardioVascular II Jun-14-2010
30 Medtronic CardioVascular II Jan-19-2010
31 Medtronic Cardiovascular III Mar-18-2009
32 Merit Medical Systems, Inc. II Feb-20-2013
33 Merit Medical Systems, Inc. II Feb-22-2010
34 Merit Medical Systems, Inc. II Jan-13-2009
35 Navilyst Medical, Inc II Jan-11-2012
36 Navilyst Medical, Inc II Oct-07-2010

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