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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
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOTEQUE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SE - WITH LIMITATIONS 2
  1.  K240464  WallFlex Biliary RX Stent System; Epic Biliary Ste ...
  2.  K242950  WallFlex Biliary PLUS RX Stent System
BOSTON SCIENTIFIC CORPORATION
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 2
COOK IRELAND LTD
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 1
DONGGUAN TT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDO GI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ENDOGI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ENDOGI MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
  SE - WITH LIMITATIONS 1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LEO MEDICAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
M.I.TECH CO., LTD.
  SE - WITH LIMITATIONS 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
S&G BIOTECH INC.
  SE - WITH LIMITATIONS 1
TAEWOONG MEDICAL CO., LTD
  SE - WITH LIMITATIONS 2

MDR Year MDR Reports MDR Events
2020 2181 2181
2021 2297 2297
2022 1749 1749
2023 1622 1622
2024 1950 1950
2025 138 138

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2174 2174
Improper or Incorrect Procedure or Method 958 958
Break 958 958
Adverse Event Without Identified Device or Use Problem 805 805
Material Puncture/Hole 613 613
Off-Label Use 560 560
Burst Container or Vessel 556 556
Material Deformation 524 524
Detachment of Device or Device Component 422 422
Difficult to Remove 402 402
Migration 358 358
Device Dislodged or Dislocated 336 336
Positioning Failure 285 285
Difficult to Advance 277 277
Activation, Positioning or Separation Problem 270 270
Leak/Splash 267 267
Use of Device Problem 265 265
Material Twisted/Bent 235 235
Activation Failure 227 227
Dent in Material 218 218
Premature Activation 168 168
Fracture 168 168
Inflation Problem 159 159
Failure to Advance 137 137
Difficult or Delayed Positioning 135 135
Entrapment of Device 115 115
Material Integrity Problem 104 104
Material Separation 89 89
Material Split, Cut or Torn 86 86
Obstruction of Flow 85 85
Physical Resistance/Sticking 84 84
Positioning Problem 77 77
Deformation Due to Compressive Stress 68 68
Defective Device 67 67
Deflation Problem 66 66
Mechanical Jam 56 56
Appropriate Term/Code Not Available 54 54
Migration or Expulsion of Device 53 53
Fluid/Blood Leak 53 53
Stretched 51 51
Device Damaged Prior to Use 50 50
Crack 49 49
Defective Component 44 44
Difficult or Delayed Activation 42 42
Unsealed Device Packaging 42 42
Failure to Deflate 40 40
Malposition of Device 40 40
Retraction Problem 37 37
Device-Device Incompatibility 35 35
Difficult to Insert 30 30

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6872 6872
No Consequences Or Impact To Patient 1569 1569
No Known Impact Or Consequence To Patient 442 442
Obstruction/Occlusion 299 299
Insufficient Information 256 256
Perforation 156 156
Foreign Body In Patient 154 154
Inflammation 133 133
Hemorrhage/Bleeding 125 125
Pancreatitis 95 95
Pain 73 73
Abdominal Pain 68 68
Thrombosis/Thrombus 56 56
No Code Available 52 52
Vascular Dissection 49 49
Restenosis 49 49
No Patient Involvement 43 43
Stenosis 41 41
Occlusion 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Device Embedded In Tissue or Plaque 34 34
Fever 32 32
Abscess 31 31
Unspecified Infection 29 29
Sepsis 29 29
Hematoma 28 28
Failure of Implant 25 25
Jaundice 24 24
Peritonitis 21 21
Vomiting 20 20
Pseudoaneurysm 20 20
No Information 19 19
Bowel Perforation 18 18
Unspecified Tissue Injury 15 15
Embolism/Embolus 15 15
Unspecified Hepatic or Biliary Problem 14 14
Thrombosis 14 14
Rupture 13 13
Nausea 13 13
Cardiac Arrest 13 13
Ischemia 12 12
Fistula 12 12
Perforation of Vessels 12 12
Septic Shock 11 11
Injury 11 11
Discomfort 11 11
Stroke/CVA 10 10
Pneumonia 10 10
Myocardial Infarction 10 10
Aneurysm 9 9

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Boston Scientific Corporation II Dec-01-2021
3 Boston Scientific Corporation II Oct-23-2020
4 Boston Scientific Corporation II Sep-12-2020
5 Cook Incorporated II Jun-27-2024
6 Cook Incorporated II Apr-12-2024
7 Cordis Corporation II Nov-12-2021
8 Cordis US Corp II Jul-11-2022
9 Hobbs Medical, Inc. II Oct-07-2022
10 Olympus Corporation of the Americas II Oct-25-2024
11 Olympus Corporation of the Americas II Jan-31-2024
12 W.L. Gore & Associates, Inc. II Feb-22-2024
13 W.L. Gore & Associates, Inc. II May-14-2021
14 Wilson-Cook Medical Inc. II Dec-01-2023
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