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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stents, drains and dilators for the biliary ducts
Regulation Description Biliary catheter and accessories.
Product CodeFGE
Regulation Number 876.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SE - WITH LIMITATIONS 3
  SUBSTANTIALLY EQUIVALENT 7
BOSTON SCIENTIFIC CORPORATION
  SE - WITH LIMITATIONS 3
  SUBSTANTIALLY EQUIVALENT 6
COOK (CANADA), INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK IRELAND LTD
  SE - WITH LIMITATIONS 2
  SUBSTANTIALLY EQUIVALENT 2
COOK IRELAND LTD.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORP.
  SE - WITH LIMITATIONS 1
CORDIS CORPORATION
  SE - WITH LIMITATIONS 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
M.I.TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDINOL LTD.
  SE - WITH LIMITATIONS 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO-TECH (NAN JING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES, INC.
  SE - WITH LIMITATIONS 1
W.L. GORE & ASSOCIATES,INC
  SE - WITH LIMITATIONS 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Stent 1454
Material Rupture 1340
Balloon 1151
Break 682
Adverse Event Without Identified Device or Use Problem 515
Catheter 506
Activation, Positioning or Separation Problem 323
Material Deformation 318
Device Dislodged or Dislocated 298
Migration or Expulsion of Device 262
Fracture 255
Difficult to Remove 250
Detachment of Device or device Component 216
Kinked 188
Material Puncture / Hole 174
Burst Container or Vessel 144
Detachment Of Device Component 142
Difficult or Delayed Positioning 141
Occlusion Within Device 118
Premature Activation 103
Partial Blockage 100
Tip 90
Entrapment of Device 78
Deflation Problem 75
Bent 71
Difficult to Advance 68
Device Subassembly 65
Positioning Failure 65
Positioning Problem 63
Leak / Splash 62
Material Separation 60
Use of Device Problem 60
Delivery System Failure 54
Failure to Advance 52
Unintended Movement 48
Defective Component 45
Activation Failure Including Expansion Failures 44
Calcified 43
Inflation Problem 38
Migration 38
Off-Label Use 37
Device Contamination with Chemical or Other Material 35
Device Damaged Prior to Use 35
Shaft 35
Hole In Material 32
Tear, Rip or Hole in Device Packaging 26
Obstruction of Flow 25
Torn Material 22
Device Packaging Compromised 21
Appropriate Term/Code Not Available 21
Insufficient Information 19
Malposition of device 18
Device Markings / Labelling Problem 18
Improper or Incorrect Procedure or Method 18
Material Integrity Problem 18
Suture 15
Seal 15
Material Frayed 15
Contamination / decontamination Problem 15
Therapy Delivered to Incorrect Body Area 15
Stretched 14
Crack 14
Retraction Problem 13
Device Operates Differently Than Expected 13
Cover 12
Fluid Leak 11
Material Perforation 11
Difficult to Insert 11
Other (for use when an appropriate device code cannot be identified) 10
Unsealed Device Packaging 10
Defective Device 9
Packaging Problem 9
Inaccurate Delivery 9
Difficult To Position 9
Component Missing 9
Label 9
Split 8
Difficult or Delayed Activation 8
Material Fragmentation 8
Material Protrusion / Extrusion 8
Device Damaged by Another Device 7
Device-Device Incompatibility 7
Problem with Sterilization 7
Material Twisted / Bent 7
Failure To Adhere Or Bond 7
Physical Resistance 6
Structural Problem 6
No Apparent Adverse Event 6
Physical Resistance / Sticking 6
Separation Failure 6
Mechanical Jam 5
Inadequacy of Device Shape and/or Size 5
Shelf Life Exceeded 5
Misfire 5
Contamination During Use 4
Device Deployer 4
Device Or Device Fragments Location Unknown 4
Device Contaminated during manufacture or shipping 4
Dent in Material 3
Locking Mechanism 3
Total Device Problems 10566

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jul-09-2019
2 Boston Scientific Corporation II Mar-14-2019
3 Boston Scientific Corporation II Jul-01-2015
4 Boston Scientific Corporation II Mar-31-2015
5 Boston Scientific Corporation II Mar-27-2015
6 Boston Scientific Corporation II Jan-10-2014
7 Cook Inc. II Feb-28-2019
8 Cook Medical Incorporated II Oct-31-2018
9 Cordis Corporation II Jan-09-2018

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