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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
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 4
BOSTON SCIENTIFIC CORPORATION
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 3
COOK (CANADA), INC.
  SUBSTANTIALLY EQUIVALENT 2
COOK IRELAND LTD
  SE - WITH LIMITATIONS 2
  SUBSTANTIALLY EQUIVALENT 2
COOK IRELAND LTD.
  SE - WITH LIMITATIONS 1
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
M.I.TECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDINOL LTD.
  SE - WITH LIMITATIONS 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NAN JING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
NAVILYST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS SURGICAL TECHNOLOGIES AMERICA
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES, INC.
  SE - WITH LIMITATIONS 1
W.L. GORE & ASSOCIATES,INC
  SE - WITH LIMITATIONS 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2015 1542 1542
2016 1451 1451
2017 1515 1515
2018 1679 1679
2019 1893 1893
2020 1279 1279

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 1990 1990
Stent 1785 1785
Balloon 1378 1378
Break 1062 1062
Adverse Event Without Identified Device or Use Problem 692 692
Catheter 639 639
Material Deformation 524 524
Activation, Positioning or SeparationProblem 442 442
Device Dislodged or Dislocated 430 430
Difficult to Remove 393 393
Material Puncture/Hole 344 344
Migration or Expulsion of Device 322 322
Detachment of Device or Device Component 310 310
Fracture 302 302
Kinked 282 282
Burst Container or Vessel 261 261
Detachment Of Device Component 196 196
Difficult or Delayed Positioning 190 190
Premature Activation 190 190
Occlusion Within Device 147 147
Difficult to Advance 132 132
Partial Blockage 126 126
Positioning Failure 126 126
Use of Device Problem 125 125
Entrapment of Device 117 117
Tip 116 116
Deflation Problem 105 105
Activation Failure 102 102
Leak/Splash 100 100
Positioning Problem 97 97
Failure to Advance 84 84
Off-Label Use 84 84
Bent 83 83
Material Twisted/Bent 81 81
Material Separation 77 77
Device Subassembly 72 72
Inflation Problem 71 71
Migration 69 69
Obstruction of Flow 68 68
Improper or Incorrect Procedure or Method 58 58
Defective Component 55 55
Unintended Movement 55 55
Delivery System Failure 54 54
Material Integrity Problem 50 50
Shaft 48 48
Hole In Material 43 43
Calcified 43 43
Insufficient Information 43 43
Device Damaged Prior to Use 41 41
Device Contamination with Chemical or Other Material 39 39
Tear, Rip or Hole in Device Packaging 39 39
Crack 36 36
Appropriate Term/Code Not Available 35 35
Malposition of Device 32 32
Torn Material 29 29
Device Operates Differently Than Expected 29 29
Device Packaging Compromised 27 27
Difficult to Insert 27 27
Inaccurate Delivery 24 24
Device Markings/Labelling Problem 23 23
Therapy Delivered to Incorrect Body Area 23 23
Physical Resistance/Sticking 22 22
Material Frayed 21 21
Defective Device 21 21
Seal 21 21
Stretched 20 20
Difficult To Position 20 20
Unsealed Device Packaging 19 19
Difficult or Delayed Activation 19 19
Contamination /Decontamination Problem 18 18
Retraction Problem 18 18
Material Fragmentation 17 17
Fluid Leak 17 17
Suture Thread 16 16
Mechanical Jam 15 15
Material Perforation 15 15
Physical Resistance 13 13
Packaging Problem 13 13
Cover 13 13
Device-Device Incompatibility 12 12
Device Contaminated During Manufacture or Shipping 12 12
Material Protrusion/Extrusion 12 12
Component Missing 11 11
Device Expiration Issue 11 11
Hub 11 11
Problem with Sterilization 10 10
Separation Failure 10 10
Device Damaged by Another Device 10 10
Split 9 9
Deformation Due to Compressive Stress 9 9
Loss of or Failure to Bond 9 9
Guidewire 9 9
Label 9 9
Failure To Adhere Or Bond 8 8
Mechanical Problem 8 8
Structural Problem 8 8
No Apparent Adverse Event 8 8
Material Split, Cut or Torn 8 8
Stylet 7 7
Misfire 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 6200 6200
No Known Impact Or Consequence To Patient 1225 1225
No Patient Involvement 365 365
Reocclusion 192 192
No Code Available 161 161
Inflammation 127 127
Device Embedded In Tissue or Plaque 125 125
Patient Problem/Medical Problem 121 121
Death 117 117
Occlusion 105 105
Foreign Body In Patient 97 97
Perforation 91 91
Unspecified Infection 89 89
Thrombosis 82 82
Pain 79 79
Stenosis 75 75
Hemorrhage/Bleeding 66 66
No Information 46 46
Jaundice 43 43
Blood Loss 39 39
Obstruction/Occlusion 31 31
Thrombus 31 31
Injury 29 29
Hematoma 28 28
Vascular System (Circulation), Impaired 26 26
Pseudoaneurysm 26 26
Embolism 25 25
Sepsis 25 25
Vascular Dissection 25 25
Fever 23 23
Ischemia 19 19
Intimal Dissection 19 19
Abdominal Pain 18 18
Hypersensitivity/Allergic reaction 17 17
Aneurysm 16 16
Claudication 16 16
Perforation of Vessels 16 16
Renal Failure 14 14
Tissue Damage 14 14
Edema 13 13
Necrosis 13 13
Abscess 13 13
Rupture 12 12
Failure of Implant 11 11
Stroke/CVA 11 11
Chest Pain 10 10
Swelling 10 10
Nausea 9 9
Reaction 9 9
Myocardial Infarction 8 8
Discomfort 7 7
Peritonitis 7 7
Vessel Or Plaque, Device Embedded In 6 6
Erosion 6 6
Bacterial Infection 6 6
Arrhythmia 5 5
Cardiac Arrest 5 5
Internal Organ Perforation 5 5
Fistula 5 5
Complaint, Ill-Defined 5 5
Urinary Tract Infection 5 5
Pneumonia 5 5
Extravasation 5 5
Aortic Dissection 5 5
Cramp(s) 5 5
Congestive Heart Failure 4 4
Vomiting 4 4
Heart Failure 4 4
Hypoxia 4 4
Purulent Discharge 4 4
Bruise/Contusion 4 4
Thromboembolism 4 4
Not Applicable 3 3
Bradycardia 3 3
Hyperbilirubinemia 3 3
Hospitalization required 3 3
Surgical procedure, additional 3 3
Shock 3 3
Congenital Defect/Deformity 3 3
Aspiration/Inhalation 3 3
Low Blood Pressure/ Hypotension 3 3
Ulcer 3 3
Pressure Sores 3 3
Surgical procedure 3 3
Foreign body, removal of 3 3
Therapy/non-surgical treatment, additional 2 2
Fluid Discharge 2 2
Chills 2 2
Transient Ischemic Attack 2 2
High Blood Pressure/ Hypertension 2 2
Gangrene 2 2
Pulmonary Embolism 2 2
Abrasion 2 2
Dyspnea 2 2
Endocarditis 2 2
Pneumothorax 2 2
Burning Sensation 2 2
Great Vessel Perforation 2 2
Ventricular Fibrillation 2 2
Suture Abrasion 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Sep-12-2020
2 Boston Scientific Corporation II Nov-25-2019
3 Boston Scientific Corporation II Jul-09-2019
4 Boston Scientific Corporation II Mar-14-2019
5 Boston Scientific Corporation II Jul-01-2015
6 Boston Scientific Corporation II Mar-31-2015
7 Boston Scientific Corporation II Mar-27-2015
8 Cook Inc. II Feb-28-2019
9 Cook Medical Incorporated II Oct-31-2018
10 Cordis Corporation II Jan-09-2018
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