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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
ASAHI INTECC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BIOTEQUE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SE - WITH LIMITATIONS 2
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 1948 1948

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2139 2139
Improper or Incorrect Procedure or Method 948 948
Break 935 935
Adverse Event Without Identified Device or Use Problem 795 795
Material Puncture/Hole 611 611
Off-Label Use 559 559
Burst Container or Vessel 552 552
Material Deformation 512 512
Detachment of Device or Device Component 411 411
Difficult to Remove 394 394
Migration 356 356
Device Dislodged or Dislocated 332 332
Positioning Failure 279 279
Difficult to Advance 270 270
Activation, Positioning or Separation Problem 268 268
Leak/Splash 267 267
Use of Device Problem 258 258
Material Twisted/Bent 228 228
Activation Failure 227 227
Dent in Material 213 213
Premature Activation 165 165
Fracture 164 164
Inflation Problem 159 159
Failure to Advance 136 136
Difficult or Delayed Positioning 129 129
Entrapment of Device 112 112
Material Integrity Problem 104 104
Material Separation 89 89
Material Split, Cut or Torn 86 86
Physical Resistance/Sticking 84 84
Obstruction of Flow 84 84
Positioning Problem 77 77
Deformation Due to Compressive Stress 66 66
Deflation Problem 66 66
Defective Device 65 65
Mechanical Jam 56 56
Appropriate Term/Code Not Available 54 54
Fluid/Blood Leak 53 53
Migration or Expulsion of Device 52 52
Stretched 51 51
Crack 49 49
Device Damaged Prior to Use 49 49
Defective Component 44 44
Difficult or Delayed Activation 42 42
Failure to Deflate 40 40
Malposition of Device 40 40
Unsealed Device Packaging 40 40
Retraction Problem 37 37
Device-Device Incompatibility 35 35
Difficult to Insert 29 29

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6742 6742
No Consequences Or Impact To Patient 1569 1569
No Known Impact Or Consequence To Patient 442 442
Obstruction/Occlusion 296 296
Insufficient Information 255 255
Perforation 155 155
Foreign Body In Patient 150 150
Inflammation 133 133
Hemorrhage/Bleeding 125 125
Pancreatitis 95 95
Pain 69 69
Abdominal Pain 68 68
Thrombosis/Thrombus 56 56
No Code Available 52 52
Vascular Dissection 49 49
Restenosis 48 48
No Patient Involvement 43 43
Stenosis 41 41
Occlusion 39 39
Device Embedded In Tissue or Plaque 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 34 34
Fever 32 32
Abscess 31 31
Sepsis 29 29
Unspecified Infection 29 29
Hematoma 28 28
Failure of Implant 25 25
Jaundice 23 23
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
Thrombosis 14 14
Unspecified Hepatic or Biliary Problem 14 14
Nausea 13 13
Cardiac Arrest 13 13
Rupture 13 13
Perforation of Vessels 12 12
Fistula 12 12
Ischemia 12 12
Discomfort 11 11
Septic Shock 11 11
Injury 11 11
Myocardial Infarction 10 10
Pneumonia 10 10
Stroke/CVA 10 10
Blood Loss 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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