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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 1790 1790

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2056 2056
Stent 1791 1791
Balloon 1380 1380
Break 1092 1092
Adverse Event Without Identified Device or Use Problem 714 714
Catheter 639 639
Material Deformation 539 539
Activation, Positioning or SeparationProblem 453 453
Device Dislodged or Dislocated 443 443
Difficult to Remove 411 411
Material Puncture/Hole 377 377
Detachment of Device or Device Component 369 369
Migration or Expulsion of Device 342 342
Fracture 309 309
Kinked 282 282
Burst Container or Vessel 269 269
Off-Label Use 236 236
Premature Activation 197 197
Detachment Of Device Component 196 196
Difficult or Delayed Positioning 192 192
Occlusion Within Device 147 147
Difficult to Advance 139 139
Positioning Failure 130 130
Use of Device Problem 128 128
Partial Blockage 126 126
Entrapment of Device 117 117
Tip 116 116
Leak/Splash 115 115
Activation Failure 115 115
Deflation Problem 110 110
Positioning Problem 101 101
Migration 99 99
Improper or Incorrect Procedure or Method 96 96
Material Twisted/Bent 94 94
Failure to Advance 93 93
Bent 83 83
Inflation Problem 82 82
Material Separation 81 81
Obstruction of Flow 78 78
Device Subassembly 72 72
Defective Component 59 59
Material Integrity Problem 58 58
Unintended Movement 55 55
Delivery System Failure 54 54
Shaft 48 48
Insufficient Information 44 44
Hole In Material 43 43
Calcified 43 43
Device Contamination with Chemical or Other Material 41 41
Device Damaged Prior to Use 41 41
Tear, Rip or Hole in Device Packaging 39 39
Appropriate Term/Code Not Available 39 39
Crack 37 37
Malposition of Device 35 35
Device Operates Differently Than Expected 29 29
Torn Material 29 29
Device Packaging Compromised 27 27
Difficult to Insert 27 27
Physical Resistance/Sticking 27 27
Inaccurate Delivery 24 24
Difficult or Delayed Activation 23 23
Device Markings/Labelling Problem 23 23
Therapy Delivered to Incorrect Body Area 23 23
Stretched 22 22
Unsealed Device Packaging 22 22
Seal 21 21
Defective Device 21 21
Material Frayed 21 21
Difficult To Position 20 20
Retraction Problem 18 18
Contamination /Decontamination Problem 18 18
Material Fragmentation 17 17
Fluid Leak 17 17
Mechanical Jam 17 17
Suture Thread 16 16
Material Perforation 15 15
Material Protrusion/Extrusion 14 14
Packaging Problem 13 13
Physical Resistance 13 13
Device-Device Incompatibility 13 13
Cover 13 13
Device Contaminated During Manufacture or Shipping 12 12
Deformation Due to Compressive Stress 12 12
Device Damaged by Another Device 11 11
Component Missing 11 11
Device Expiration Issue 11 11
Hub 11 11
Loss of or Failure to Bond 10 10
Problem with Sterilization 10 10
Separation Failure 10 10
Structural Problem 10 10
Split 9 9
No Apparent Adverse Event 9 9
Guidewire 9 9
Label 9 9
Failure To Adhere Or Bond 8 8
Material Split, Cut or Torn 8 8
Mechanical Problem 8 8
Stylet 7 7
Dent in Material 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 6491 6491
No Known Impact Or Consequence To Patient 1361 1361
No Patient Involvement 373 373
Reocclusion 193 193
No Code Available 172 172
Inflammation 143 143
Device Embedded In Tissue or Plaque 127 127
Patient Problem/Medical Problem 121 121
Death 117 117
Occlusion 115 115
Foreign Body In Patient 105 105
Perforation 98 98
Unspecified Infection 90 90
Pain 84 84
Thrombosis 84 84
Stenosis 75 75
Hemorrhage/Bleeding 75 75
No Information 55 55
Jaundice 44 44
Blood Loss 39 39
Obstruction/Occlusion 36 36
Thrombus 31 31
Injury 30 30
Hematoma 28 28
Vascular Dissection 26 26
Vascular System (Circulation), Impaired 26 26
Pseudoaneurysm 26 26
Embolism 25 25
Sepsis 25 25
Fever 25 25
Abdominal Pain 23 23
Intimal Dissection 19 19
Ischemia 19 19
Hypersensitivity/Allergic reaction 18 18
Failure of Implant 17 17
Aneurysm 16 16
Perforation of Vessels 16 16
Claudication 16 16
Abscess 15 15
Renal Failure 14 14
Tissue Damage 14 14
Necrosis 13 13
Edema 13 13
Rupture 12 12
Stroke/CVA 11 11
Chest Pain 10 10
Swelling 10 10
Nausea 9 9
Reaction 9 9
Myocardial Infarction 8 8
Discomfort 8 8
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
Pneumonia 5 5
Urinary Tract Infection 5 5
Thromboembolism 5 5
Extravasation 5 5
Aortic Dissection 5 5
Cramp(s) 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Congestive Heart Failure 4 4
Vomiting 4 4
Heart Failure 4 4
Hypoxia 4 4
Bruise/Contusion 4 4
Purulent Discharge 4 4
Bradycardia 3 3
Hyperbilirubinemia 3 3
Laceration(s) 3 3
Hospitalization required 3 3
Surgical procedure, additional 3 3
Shock 3 3
Not Applicable 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
Bowel Perforation 2 2
Fluid Discharge 2 2
Chills 2 2
Transient Ischemic Attack 2 2
High Blood Pressure/ Hypertension 2 2
Gangrene 2 2
Air Embolism 2 2
Pulmonary Embolism 2 2
Abrasion 2 2
Dyspnea 2 2
Endocarditis 2 2
Valvular Stenosis 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Oct-23-2020
2 Boston Scientific Corporation II Sep-12-2020
3 Boston Scientific Corporation II Nov-25-2019
4 Boston Scientific Corporation II Jul-09-2019
5 Boston Scientific Corporation II Mar-14-2019
6 Boston Scientific Corporation II Jul-01-2015
7 Boston Scientific Corporation II Mar-31-2015
8 Boston Scientific Corporation II Mar-27-2015
9 Cook Inc. II Feb-28-2019
10 Cook Medical Incorporated II Oct-31-2018
11 Cordis Corporation II Jan-09-2018
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