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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
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 1954 1954
2025 468 468

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2250 2250
Break 1004 1004
Improper or Incorrect Procedure or Method 973 973
Adverse Event Without Identified Device or Use Problem 847 847
Material Puncture/Hole 616 616
Burst Container or Vessel 584 584
Off-Label Use 564 564
Material Deformation 544 544
Detachment of Device or Device Component 440 440
Difficult to Remove 410 410
Migration 370 370
Device Dislodged or Dislocated 343 343
Positioning Failure 300 300
Leak/Splash 286 286
Activation, Positioning or Separation Problem 279 279
Use of Device Problem 278 278
Difficult to Advance 278 278
Material Twisted/Bent 250 250
Activation Failure 230 230
Dent in Material 226 226
Premature Activation 172 172
Fracture 170 170
Inflation Problem 167 167
Failure to Advance 141 141
Difficult or Delayed Positioning 138 138
Entrapment of Device 123 123
Material Integrity Problem 108 108
Material Split, Cut or Torn 96 96
Material Separation 94 94
Obstruction of Flow 85 85
Physical Resistance/Sticking 85 85
Positioning Problem 79 79
Defective Device 72 72
Deformation Due to Compressive Stress 69 69
Deflation Problem 66 66
Crack 59 59
Fluid/Blood Leak 59 59
Mechanical Jam 56 56
Appropriate Term/Code Not Available 54 54
Stretched 54 54
Migration or Expulsion of Device 53 53
Device Damaged Prior to Use 50 50
Defective Component 44 44
Unsealed Device Packaging 43 43
Malposition of Device 43 43
Difficult or Delayed Activation 42 42
Failure to Deflate 41 41
Retraction Problem 38 38
Device-Device Incompatibility 36 36
Difficult to Insert 31 31

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7168 7168
No Consequences Or Impact To Patient 1569 1569
No Known Impact Or Consequence To Patient 442 442
Obstruction/Occlusion 308 308
Insufficient Information 266 266
Perforation 161 161
Foreign Body In Patient 159 159
Inflammation 135 135
Hemorrhage/Bleeding 127 127
Pancreatitis 96 96
Pain 73 73
Abdominal Pain 68 68
Thrombosis/Thrombus 59 59
No Code Available 52 52
Restenosis 49 49
Vascular Dissection 49 49
No Patient Involvement 43 43
Stenosis 42 42
Occlusion 39 39
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 36 36
Device Embedded In Tissue or Plaque 35 35
Abscess 34 34
Fever 32 32
Sepsis 30 30
Unspecified Infection 29 29
Hematoma 28 28
Failure of Implant 25 25
Jaundice 24 24
Peritonitis 21 21
Pseudoaneurysm 21 21
Vomiting 20 20
No Information 19 19
Bowel Perforation 18 18
Unspecified Tissue Injury 16 16
Embolism/Embolus 16 16
Thrombosis 14 14
Cardiac Arrest 14 14
Unspecified Hepatic or Biliary Problem 14 14
Discomfort 13 13
Rupture 13 13
Nausea 13 13
Ischemia 12 12
Perforation of Vessels 12 12
Fistula 12 12
Septic Shock 11 11
Injury 11 11
Pneumonia 10 10
Stroke/CVA 10 10
Myocardial Infarction 10 10
Swelling/ Edema 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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