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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 1623 1623
2024 1396 1396

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2453 2453
Break 1052 1052
Improper or Incorrect Procedure or Method 901 901
Adverse Event Without Identified Device or Use Problem 803 803
Material Puncture/Hole 779 779
Material Deformation 682 682
Burst Container or Vessel 639 639
Off-Label Use 564 564
Detachment of Device or Device Component 472 472
Difficult to Remove 429 429
Migration 377 377
Device Dislodged or Dislocated 372 372
Activation, Positioning or Separation Problem 357 357
Difficult to Advance 307 307
Use of Device Problem 306 306
Positioning Failure 273 273
Leak/Splash 259 259
Activation Failure 250 250
Material Twisted/Bent 223 223
Fracture 219 219
Dent in Material 209 209
Premature Activation 190 190
Inflation Problem 155 155
Difficult or Delayed Positioning 155 155
Failure to Advance 146 146
Entrapment of Device 140 140
Material Separation 106 106
Material Integrity Problem 106 106
Obstruction of Flow 98 98
Positioning Problem 97 97
Physical Resistance/Sticking 89 89
Material Split, Cut or Torn 81 81
Deflation Problem 79 79
Migration or Expulsion of Device 73 73
Defective Device 69 69
Deformation Due to Compressive Stress 67 67
Mechanical Jam 62 62
Appropriate Term/Code Not Available 55 55
Stretched 52 52
Fluid/Blood Leak 51 51
Crack 51 51
Defective Component 50 50
Difficult or Delayed Activation 50 50
Device Damaged Prior to Use 47 47
Unsealed Device Packaging 46 46
Tear, Rip or Hole in Device Packaging 45 45
Malposition of Device 43 43
Retraction Problem 41 41
Device-Device Incompatibility 39 39
Failure to Deflate 35 35

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6315 6315
No Consequences Or Impact To Patient 2786 2786
No Known Impact Or Consequence To Patient 800 800
Insufficient Information 244 244
Obstruction/Occlusion 227 227
Foreign Body In Patient 165 165
Perforation 164 164
Inflammation 161 161
Hemorrhage/Bleeding 125 125
No Patient Involvement 97 97
Pancreatitis 81 81
No Code Available 81 81
Pain 77 77
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 48 48
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
Unspecified Tissue Injury 15 15
Renal Failure 15 15
Rupture 14 14
Aneurysm 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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