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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
Product CodeFGE
Regulation Number 876.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOTEQUE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SE - WITH LIMITATIONS 1
BOSTON SCIENTIFIC CORPORATION
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 2
BRIGHTWATER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
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
M.I.TECH CO., LTD.
  SE - WITH LIMITATIONS 2
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
2019 1895 1895
2020 2181 2181
2021 2297 2297
2022 1749 1749
2023 1624 1624
2024 1238 1238

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2409 2409
Break 1040 1040
Improper or Incorrect Procedure or Method 890 890
Material Puncture/Hole 779 779
Adverse Event Without Identified Device or Use Problem 777 777
Material Deformation 672 672
Burst Container or Vessel 630 630
Off-Label Use 560 560
Detachment of Device or Device Component 464 464
Difficult to Remove 426 426
Migration 373 373
Device Dislodged or Dislocated 367 367
Activation, Positioning or Separation Problem 357 357
Difficult to Advance 304 304
Use of Device Problem 299 299
Positioning Failure 266 266
Leak/Splash 254 254
Activation Failure 247 247
Material Twisted/Bent 220 220
Fracture 217 217
Dent in Material 206 206
Premature Activation 187 187
Difficult or Delayed Positioning 154 154
Inflation Problem 152 152
Failure to Advance 143 143
Entrapment of Device 139 139
Material Integrity Problem 105 105
Material Separation 103 103
Obstruction of Flow 98 98
Positioning Problem 95 95
Physical Resistance/Sticking 88 88
Material Split, Cut or Torn 79 79
Deflation Problem 78 78
Migration or Expulsion of Device 72 72
Deformation Due to Compressive Stress 66 66
Defective Device 66 66
Mechanical Jam 62 62
Appropriate Term/Code Not Available 55 55
Stretched 51 51
Crack 50 50
Difficult or Delayed Activation 49 49
Defective Component 49 49
Fluid/Blood Leak 48 48
Device Damaged Prior to Use 46 46
Unsealed Device Packaging 44 44
Tear, Rip or Hole in Device Packaging 44 44
Malposition of Device 43 43
Retraction Problem 41 41
Device-Device Incompatibility 39 39
Failure to Deflate 32 32

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6177 6177
No Consequences Or Impact To Patient 2786 2786
No Known Impact Or Consequence To Patient 800 800
Insufficient Information 239 239
Obstruction/Occlusion 219 219
Foreign Body In Patient 164 164
Perforation 163 163
Inflammation 161 161
Hemorrhage/Bleeding 124 124
No Patient Involvement 97 97
Pancreatitis 81 81
No Code Available 81 81
Pain 76 76
Occlusion 66 66
Device Embedded In Tissue or Plaque 64 64
Abdominal Pain 55 55
Stenosis 54 54
Thrombosis/Thrombus 54 54
Vascular Dissection 49 49
Restenosis 46 46
Unspecified Infection 41 41
Patient Problem/Medical Problem 40 40
Sepsis 37 37
Fever 36 36
Hematoma 36 36
Abscess 34 34
Blood Loss 33 33
Reocclusion 30 30
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 30 30
Failure of Implant 28 28
Jaundice 27 27
Thrombosis 25 25
Pseudoaneurysm 23 23
Injury 23 23
No Information 23 23
Death 21 21
Peritonitis 21 21
Bowel Perforation 18 18
Ischemia 17 17
Renal Failure 15 15
Rupture 14 14
Aneurysm 14 14
Unspecified Tissue Injury 14 14
Discomfort 14 14
Vomiting 13 13
Perforation of Vessels 13 13
Embolism 13 13
Thrombus 13 13
Unspecified Hepatic or Biliary Problem 12 12
Embolism/Embolus 12 12

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 Boston Scientific Corporation II Nov-25-2019
6 Boston Scientific Corporation II Jul-09-2019
7 Boston Scientific Corporation II Mar-14-2019
8 Cook Inc. II Feb-28-2019
9 Cook Incorporated II Jun-27-2024
10 Cook Incorporated II Apr-12-2024
11 Cordis Corporation II Nov-12-2021
12 Cordis US Corp II Jul-11-2022
13 Hobbs Medical, Inc. II Oct-07-2022
14 Olympus Corporation of the Americas II Jan-31-2024
15 W.L. Gore & Associates, Inc. II Feb-22-2024
16 W.L. Gore & Associates, Inc. II May-14-2021
17 Wilson-Cook Medical Inc. II Dec-01-2023
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