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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
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTEQUE CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 2
BRIGHTWATER MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND
  SUBSTANTIALLY EQUIVALENT 1
COOK IRELAND LTD
  SE - WITH LIMITATIONS 2
  SUBSTANTIALLY EQUIVALENT 3
COOK IRELAND LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENDO GI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ENDOGI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ENDOGI MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
M.I.TECH CO., LTD.
  SE - WITH LIMITATIONS 2
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
TAEWOONG MEDICAL CO., LTD
  SE - WITH LIMITATIONS 1
W.L. GORE & ASSOCIATES, INC.
  SE - WITH LIMITATIONS 1
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 1515 1515
2018 1680 1680
2019 1895 1895
2020 2182 2182
2021 2302 2302
2022 1468 1468

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2379 2379
Break 1115 1115
Material Puncture/Hole 780 780
Adverse Event Without Identified Device or Use Problem 758 758
Material Deformation 656 656
Improper or Incorrect Procedure or Method 555 555
Burst Container or Vessel 534 534
Detachment of Device or Device Component 454 454
Off-Label Use 453 453
Difficult to Remove 407 407
Activation, Positioning or Separation Problem 403 403
Device Dislodged or Dislocated 367 367
Fracture 287 287
Migration 250 250
Difficult to Advance 238 238
Use of Device Problem 229 229
Leak/Splash 219 219
Migration or Expulsion of Device 219 219
Positioning Failure 209 209
Activation Failure 197 197
Premature Activation 194 194
Material Twisted/Bent 164 164
Difficult or Delayed Positioning 151 151
Inflation Problem 135 135
Dent in Material 132 132
Entrapment of Device 125 125
Failure to Advance 121 121
Positioning Problem 113 113
Deflation Problem 102 102
Obstruction of Flow 101 101
Material Integrity Problem 94 94
Kinked 93 93
Material Separation 91 91
Detachment Of Device Component 81 81
Appropriate Term/Code Not Available 59 59
Defective Component 58 58
Crack 57 57
Device Damaged Prior to Use 54 54
Unintended Movement 54 54
Physical Resistance/Sticking 53 53
Delivery System Failure 51 51
Partial Blockage 51 51
Defective Device 48 48
Occlusion Within Device 47 47
Malposition of Device 43 43
Tear, Rip or Hole in Device Packaging 43 43
Mechanical Jam 43 43
Device Contamination with Chemical or Other Material 43 43
Bent 42 42
Material Split, Cut or Torn 42 42
Insufficient Information 41 41
Difficult or Delayed Activation 41 41
Retraction Problem 38 38
Stretched 37 37
Therapy Delivered to Incorrect Body Area 37 37
Deformation Due to Compressive Stress 36 36
Unsealed Device Packaging 33 33
Device-Device Incompatibility 26 26
Fluid/Blood Leak 25 25
Calcified 24 24
Material Fragmentation 23 23
Hole In Material 23 23
Material Protrusion/Extrusion 22 22
Difficult to Insert 20 20
Loss of or Failure to Bond 18 18
Device Markings/Labelling Problem 18 18
Contamination /Decontamination Problem 18 18
Material Perforation 17 17
Device Contaminated During Manufacture or Shipping 17 17
Structural Problem 16 16
Inaccurate Delivery 15 15
Problem with Sterilization 14 14
Device Packaging Compromised 13 13
Packaging Problem 13 13
Difficult To Position 12 12
Complete Blockage 12 12
Material Frayed 11 11
Device Operates Differently Than Expected 11 11
Misfire 11 11
Component Missing 10 10
No Apparent Adverse Event 10 10
Device Damaged by Another Device 9 9
Mechanical Problem 9 9
Torn Material 8 8
Activation Problem 8 8
Separation Failure 7 7
Patient-Device Incompatibility 7 7
Unraveled Material 7 7
Contamination 7 7
Physical Resistance 6 6
Difficult to Open or Remove Packaging Material 6 6
Failure To Adhere Or Bond 5 5
Product Quality Problem 5 5
Separation Problem 5 5
Patient Device Interaction Problem 5 5
Nonstandard Device 4 4
Device Difficult to Setup or Prepare 4 4
Unintended Ejection 4 4
Material Disintegration 4 4
Device Handling Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 4898 4898
No Clinical Signs, Symptoms or Conditions 3398 3398
No Known Impact Or Consequence To Patient 1188 1188
No Patient Involvement 220 220
Inflammation 174 174
Insufficient Information 172 172
Foreign Body In Patient 155 155
Perforation 154 154
No Code Available 146 146
Obstruction/Occlusion 145 145
Hemorrhage/Bleeding 117 117
Device Embedded In Tissue or Plaque 101 101
Occlusion 97 97
Patient Problem/Medical Problem 91 91
Reocclusion 88 88
Pain 84 84
Stenosis 71 71
Death 69 69
Unspecified Infection 63 63
Thrombosis 58 58
Thrombosis/Thrombus 46 46
Vascular Dissection 43 43
Abdominal Pain 41 41
Restenosis 39 39
Hematoma 38 38
Blood Loss 38 38
No Information 37 37
Pancreatitis 37 37
Failure of Implant 32 32
Fever 32 32
Injury 28 28
Jaundice 28 28
Sepsis 26 26
Pseudoaneurysm 26 26
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 21 21
Vascular System (Circulation), Impaired 20 20
Thrombus 20 20
Embolism 20 20
Abscess 20 20
Aneurysm 20 20
Perforation of Vessels 19 19
Ischemia 17 17
Peritonitis 16 16
Renal Failure 15 15
Bowel Perforation 15 15
Rupture 13 13
Edema 13 13
Fistula 12 12
Stroke/CVA 12 12
Chest Pain 12 12
Bacterial Infection 12 12
Myocardial Infarction 11 11
Necrosis 11 11
Hypersensitivity/Allergic reaction 10 10
Erosion 10 10
Intimal Dissection 10 10
Discomfort 9 9
Claudication 9 9
Unspecified Tissue Injury 9 9
Embolism/Embolus 9 9
Swelling 8 8
Low Blood Pressure/ Hypotension 8 8
Nausea 8 8
Internal Organ Perforation 7 7
Cardiac Arrest 7 7
Vomiting 7 7
Urinary Tract Infection 6 6
Tissue Damage 6 6
Reaction 6 6
Vessel Or Plaque, Device Embedded In 6 6
Arrhythmia 6 6
Pneumonia 6 6
Laceration(s) 6 6
Swelling/ Edema 6 6
Gastrointestinal Hemorrhage 5 5
Hypoxia 5 5
Bruise/Contusion 5 5
Purulent Discharge 5 5
Aortic Dissection 5 5
Thromboembolism 5 5
Septic Shock 5 5
Cramp(s) 5 5
Complaint, Ill-Defined 5 5
Pleural Effusion 4 4
Congestive Heart Failure 4 4
Bradycardia 4 4
Hemoptysis 4 4
Pneumothorax 4 4
Rash 3 3
High Blood Pressure/ Hypertension 3 3
Hyperbilirubinemia 3 3
Extravasation 3 3
Cellulitis 3 3
Shock 3 3
Vasoconstriction 3 3
Ulcer 3 3
Pressure Sores 3 3
Heart Failure 3 3
Fluid Discharge 3 3
Great Vessel Perforation 3 3

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 Medical Incorporated II Oct-31-2018
10 Cordis Corporation II Nov-12-2021
11 Cordis Corporation II Jan-09-2018
12 Cordis US Corp II Jul-11-2022
13 Hobbs Medical, Inc. II Oct-07-2022
14 W.L. Gore & Associates, Inc. II May-14-2021
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