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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
  SUBSTANTIALLY EQUIVALENT 1
  SE - WITH LIMITATIONS 2
BOSTON SCIENTIFIC CORPORATION
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND, LTD.
  SUBSTANTIALLY EQUIVALENT 2
DONGGUAN TT MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
ENDO GI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ENDOGI MEDICAL, LTD.
  SE - WITH LIMITATIONS 1
GIE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 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
MEDI-GLOBE GMBH
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
MIRCO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
Q3 MEDICAL USA, LLC (C/O Q3 MEDICAL DEVICES LTD.)
  SUBSTANTIALLY EQUIVALENT 1
S&G BIOTECH, INC.
  SE - WITH LIMITATIONS 2
SOFTAC MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
TAEWOONG MEDICAL CO., LTD.
  SE - WITH LIMITATIONS 3
ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 2297 2304
2022 1749 1759
2023 1615 1639
2024 1947 1955
2025 1944 1944
2026 913 913

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2272 2275
Adverse Event Without Identified Device or Use Problem 1127 1131
Break 1126 1132
Improper or Incorrect Procedure or Method 947 950
Burst Container or Vessel 639 639
Material Deformation 556 562
Material Puncture/Hole 540 543
Detachment of Device or Device Component 431 434
Difficult to Remove 411 417
Positioning Failure 371 371
Migration 366 368
Off-Label Use 351 355
Leak/Splash 345 346
Device Dislodged or Dislocated 333 333
Use of Device Problem 328 331
Dent in Material 299 299
Difficult to Advance 273 274
Activation Failure 269 272
Material Twisted/Bent 263 265
Activation, Positioning or Separation Problem 262 264
Inflation Problem 247 247
Failure to Advance 169 169
Premature Activation 165 165
Difficult or Delayed Positioning 159 159
Fracture 158 160
Material Split, Cut or Torn 138 138
Entrapment of Device 137 137
Fluid/Blood Leak 108 110
Material Integrity Problem 107 108
Material Separation 89 93
Deformation Due to Compressive Stress 76 77
Positioning Problem 74 74
Physical Resistance/Sticking 73 74
Crack 68 68
Failure to Deflate 64 64
Defective Device 62 62
Deflation Problem 56 56
Obstruction of Flow 54 54
Stretched 52 53
Device Damaged Prior to Use 50 51
Mechanical Jam 46 47
Material Protrusion/Extrusion 44 44
Tear, Rip or Hole in Device Packaging 44 44
Retraction Problem 39 40
Malposition of Device 38 39
Defective Component 38 38
Device Contaminated During Manufacture or Shipping 38 38
Device-Device Incompatibility 37 37
Unsealed Device Packaging 37 37
Difficult to Insert 33 33

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9004 9032
Insufficient Information 308 314
Obstruction/Occlusion 287 290
Foreign Body In Patient 174 178
Perforation 170 171
No Consequences Or Impact To Patient 127 127
Hemorrhage/Blood Loss/Bleeding 121 121
Pancreatitis 95 96
Cholangitis 86 86
Pain 79 82
Inflammation 76 76
Restenosis 73 73
Abdominal Pain 68 68
Thrombosis/Thrombus 62 62
Vascular Dissection 48 48
No Known Impact Or Consequence To Patient 40 40
Fever 39 39
Stenosis 38 40
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 38 38
Unspecified Infection 38 39
Abscess 35 35
Sepsis 32 32
Hematoma 27 27
Vomiting 27 27
Peritonitis 22 23
Device Embedded In Tissue or Plaque 22 23
Embolism/Embolus 19 19
Unspecified Tissue Injury 18 18
Pseudoaneurysm 17 18
Jaundice 17 17
Failure of Implant 16 20
Nausea 16 16
Fistula 15 15
Bowel Perforation 15 15
Unspecified Hepatic or Biliary Problem 15 15
Bacterial Infection 12 12
Discomfort 12 13
Swelling/ Edema 12 12
Perforation of Vessels 11 11
Rupture 11 11
Septic Shock 11 11
Biliary Leak 11 11
Cardiac Arrest 10 10
Urinary Tract Infection 9 9
Ulcer 8 8
Pneumonia 8 8
Gastrointestinal Hemorrhage 8 8
Low Blood Pressure/ Hypotension 7 7
Ischemia 7 7
Aneurysm 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Aomori Olympus Co., Ltd. II Feb-05-2021
2 Boston Scientific Corporation II Jul-01-2026
3 Boston Scientific Corporation II Sep-23-2025
4 Boston Scientific Corporation II Dec-01-2021
5 Cook Incorporated II Apr-06-2026
6 Cook Incorporated II Jun-27-2024
7 Cook Incorporated II Apr-12-2024
8 Cordis Corporation II Nov-12-2021
9 Cordis US Corp II Jul-11-2022
10 Hobbs Medical, Inc. II Oct-07-2022
11 Olympus Corporation of the Americas II Oct-25-2024
12 Olympus Corporation of the Americas II Jan-31-2024
13 W.L. Gore & Associates, Inc. II Feb-22-2024
14 W.L. Gore & Associates, Inc. II May-14-2021
15 Wilson-Cook Medical Inc. II Dec-01-2023
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