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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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, 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
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 579 579

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2179 2179
Break 1036 1036
Material Puncture/Hole 765 765
Adverse Event Without Identified Device or Use Problem 685 685
Material Deformation 618 618
Burst Container or Vessel 491 491
Improper or Incorrect Procedure or Method 441 441
Detachment of Device or Device Component 423 423
Off-Label Use 394 394
Difficult to Remove 385 385
Activation, Positioning or SeparationProblem 371 371
Device Dislodged or Dislocated 337 337
Fracture 269 269
Migration or Expulsion of Device 216 216
Leak/Splash 209 209
Migration 206 206
Difficult to Advance 202 202
Use of Device Problem 202 202
Positioning Failure 190 190
Activation Failure 181 181
Premature Activation 180 180
Material Twisted/Bent 158 158
Difficult or Delayed Positioning 142 142
Inflation Problem 122 122
Entrapment of Device 111 111
Failure to Advance 109 109
Positioning Problem 105 105
Dent in Material 94 94
Deflation Problem 94 94
Kinked 93 93
Obstruction of Flow 90 90
Material Integrity Problem 89 89
Material Separation 88 88
Detachment Of Device Component 81 81
Appropriate Term/Code Not Available 59 59
Defective Component 55 55
Unintended Movement 54 54
Crack 53 53
Partial Blockage 51 51
Delivery System Failure 51 51
Physical Resistance/Sticking 51 51
Occlusion Within Device 47 47
Device Damaged Prior to Use 43 43
Bent 42 42
Tear, Rip or Hole in Device Packaging 40 40
Malposition of Device 39 39
Insufficient Information 39 39
Device Contamination with Chemical or Other Material 38 38
Defective Device 38 38
Material Split, Cut or Torn 38 38
Difficult or Delayed Activation 37 37
Mechanical Jam 36 36
Retraction Problem 36 36
Therapy Delivered to Incorrect Body Area 35 35
Stretched 33 33
Deformation Due to Compressive Stress 31 31
Unsealed Device Packaging 30 30
Calcified 24 24
Device-Device Incompatibility 24 24
Fluid Leak 23 23
Material Fragmentation 23 23
Hole In Material 23 23
Difficult to Insert 19 19
Contamination /Decontamination Problem 18 18
Material Protrusion/Extrusion 17 17
Loss of or Failure to Bond 17 17
Device Contaminated During Manufacture or Shipping 16 16
Device Markings/Labelling Problem 16 16
Material Perforation 16 16
Inaccurate Delivery 15 15
Structural Problem 14 14
Device Packaging Compromised 13 13
Packaging Problem 12 12
Difficult To Position 12 12
Problem with Sterilization 12 12
Device Operates Differently Than Expected 11 11
Misfire 11 11
Component Missing 10 10
No Apparent Adverse Event 10 10
Material Frayed 10 10
Device Damaged by Another Device 9 9
Torn Material 8 8
Mechanical Problem 8 8
Activation Problem 8 8
Separation Failure 7 7
Physical Resistance 6 6
Patient-Device Incompatibility 6 6
Difficult to Open or Remove Packaging Material 6 6
Product Quality Problem 5 5
Unraveled Material 5 5
Failure To Adhere Or Bond 5 5
Separation Problem 5 5
Patient Device Interaction Problem 5 5
Unintended Ejection 4 4
Material Disintegration 4 4
Device Difficult to Setup or Prepare 4 4
Device Handling Problem 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Failure to Align 3 3
Noise, Audible 3 3

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 2650 2650
No Known Impact Or Consequence To Patient 1188 1188
No Patient Involvement 220 220
Inflammation 147 147
No Code Available 146 146
Foreign Body In Patient 137 137
Insufficient Information 134 134
Perforation 128 128
Obstruction/Occlusion 119 119
Hemorrhage/Bleeding 103 103
Occlusion 97 97
Device Embedded In Tissue or Plaque 97 97
Patient Problem/Medical Problem 91 91
Reocclusion 88 88
Pain 78 78
Stenosis 70 70
Death 69 69
Thrombosis 58 58
Unspecified Infection 54 54
Blood Loss 38 38
Thrombosis/Thrombus 37 37
No Information 37 37
Hematoma 36 36
Restenosis 35 35
Vascular Dissection 34 34
Injury 28 28
Jaundice 28 28
Abdominal Pain 28 28
Pancreatitis 27 27
Sepsis 25 25
Pseudoaneurysm 25 25
Fever 23 23
Failure of Implant 21 21
Embolism 20 20
Vascular System (Circulation), Impaired 20 20
Thrombus 20 20
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Abscess 18 18
Aneurysm 17 17
Ischemia 17 17
Perforation of Vessels 17 17
Renal Failure 15 15
Peritonitis 13 13
Edema 13 13
Stroke/CVA 12 12
Chest Pain 12 12
Fistula 11 11
Bacterial Infection 11 11
Necrosis 11 11
Myocardial Infarction 11 11
Rupture 11 11
Bowel Perforation 10 10
Hypersensitivity/Allergic reaction 10 10
Erosion 10 10
Intimal Dissection 10 10
Claudication 9 9
Discomfort 8 8
Swelling 8 8
Low Blood Pressure/ Hypotension 8 8
Unspecified Tissue Injury 8 8
Embolism/Embolus 7 7
Nausea 7 7
Internal Organ Perforation 7 7
Pneumonia 6 6
Laceration(s) 6 6
Vessel Or Plaque, Device Embedded In 6 6
Arrhythmia 6 6
Cardiac Arrest 6 6
Tissue Damage 6 6
Reaction 6 6
Complaint, Ill-Defined 5 5
Aortic Dissection 5 5
Thromboembolism 5 5
Vomiting 5 5
Urinary Tract Infection 5 5
Cramp(s) 5 5
Bruise/Contusion 5 5
Purulent Discharge 5 5
Gastrointestinal Hemorrhage 5 5
Swelling/ Edema 5 5
Congestive Heart Failure 4 4
Bradycardia 4 4
Hypoxia 4 4
Hemoptysis 4 4
Pneumothorax 4 4
Pleural Effusion 4 4
Septic Shock 4 4
Shock 3 3
Vasoconstriction 3 3
Heart Failure 3 3
Ulcer 3 3
Pressure Sores 3 3
Fluid Discharge 3 3
Great Vessel Perforation 3 3
Rash 3 3
High Blood Pressure/ Hypertension 3 3
Extravasation 3 3
Cellulitis 3 3
Dyspnea 2 2

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 W.L. Gore & Associates, Inc. II May-14-2021
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