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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 filter, intravascular, cardiovascular
Product CodeDTK
Regulation Number 870.3375
Device Class 2


Premarket Reviews
ManufacturerDecision
BD
  SUBSTANTIALLY EQUIVALENT 1
WILLIAM COOK EUROPE APS
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2019 6467 6474
2020 5404 5404
2021 5357 5516
2022 2191 2196
2023 584 584
2024 114 114

Device Problems MDRs with this Device Problem Events in those MDRs
Structural Problem 4668 4668
Insufficient Information 4029 4029
Appropriate Term/Code Not Available 4007 4007
Difficult to Remove 2939 2947
Device Tipped Over 2396 2396
Malposition of Device 2212 2264
Unintended Movement 2002 2001
Patient Device Interaction Problem 1879 1932
Detachment of Device or Device Component 1737 1747
Adverse Event Without Identified Device or Use Problem 1464 1464
Obstruction of Flow 1314 1314
Fracture 1297 1297
Patient-Device Incompatibility 1261 1362
Migration or Expulsion of Device 1010 1013
Migration 985 987
Failure to Align 973 973
Positioning Problem 585 587
Inadequate Filtration Process 320 320
Entrapment of Device 288 288
Material Deformation 280 282
Activation Failure 269 269
Therapeutic or Diagnostic Output Failure 123 123
Failure to Advance 121 121
Break 107 107
Difficult or Delayed Activation 105 105
Activation, Positioning or Separation Problem 94 94
Improper or Incorrect Procedure or Method 90 90
Material Perforation 86 86
Material Twisted/Bent 76 76
Difficult to Advance 52 52
Defective Device 49 49
Activation Problem 49 49
Material Puncture/Hole 49 49
Premature Activation 40 40
Deformation Due to Compressive Stress 35 35
Difficult to Insert 34 34
Physical Resistance/Sticking 33 33
Device Dislodged or Dislocated 33 33
Defective Component 25 25
Positioning Failure 25 25
Retraction Problem 23 23
Difficult to Open or Close 21 21
Output Problem 21 21
Complete Blockage 16 16
Material Separation 15 15
Material Split, Cut or Torn 14 14
Difficult or Delayed Positioning 12 12
Difficult or Delayed Separation 11 11
Unexpected Therapeutic Results 11 11
Material Fragmentation 11 11
Failure to Unfold or Unwrap 11 11
Material Protrusion/Extrusion 10 10
Off-Label Use 10 10
Device Misassembled During Manufacturing /Shipping 10 10
Partial Blockage 8 8
Sharp Edges 8 8
Coagulation in Device or Device Ingredient 8 8
Connection Problem 6 6
No Apparent Adverse Event 6 6
Device-Device Incompatibility 6 6
Difficult to Fold, Unfold or Collapse 6 6
Device Contamination with Chemical or Other Material 5 5
Therapy Delivered to Incorrect Body Area 5 5
Component Incompatible 5 5
Crack 5 5
Collapse 5 5
Loss of or Failure to Bond 5 5
Component Missing 4 4
Material Frayed 4 4
Misassembled 4 4
Tear, Rip or Hole in Device Packaging 4 4
Mechanical Jam 4 4
Device Damaged by Another Device 3 3
Peeled/Delaminated 3 3
Inadequacy of Device Shape and/or Size 3 3
Disconnection 3 3
Missing Information 3 3
Use of Device Problem 3 3
Unraveled Material 2 2
Contamination 2 2
Premature Separation 2 2
Impedance Problem 2 2
Material Erosion 2 2
Loose or Intermittent Connection 2 2
Difficult to Open or Remove Packaging Material 2 2
Mechanical Problem 2 2
Nonstandard Device 2 2
Separation Problem 2 2
Fitting Problem 2 2
Poor Quality Image 2 2
Detachment Of Device Component 1 1
Incomplete or Inadequate Connection 1 1
Incomplete or Missing Packaging 1 1
Expulsion 1 1
Device Handling Problem 1 1
Stretched 1 1
Device Slipped 1 1
Packaging Problem 1 1
Ejection Problem 1 1
Filling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 7451 7451
No Information 4210 4210
Internal Organ Perforation 3914 3914
Perforation 2163 2163
Pain 2092 2092
No Clinical Signs, Symptoms or Conditions 1846 2018
Anxiety 1793 1793
Insufficient Information 1696 1696
No Consequences Or Impact To Patient 1570 1577
Pulmonary Embolism 1407 1408
Abdominal Pain 1293 1293
Thrombosis 1094 1094
Vessel Or Plaque, Device Embedded In 925 925
Thrombosis/Thrombus 923 923
Device Embedded In Tissue or Plaque 809 809
Depression 687 687
Stenosis 676 676
Occlusion 652 652
Coagulation Disorder 522 522
Dyspnea 476 476
Chest Pain 475 475
No Code Available 419 419
Thrombus 394 394
Obstruction/Occlusion 324 324
Injury 301 301
No Known Impact Or Consequence To Patient 289 289
Great Vessel Perforation 280 280
Death 258 258
Foreign Body In Patient 190 190
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 150 150
Hemorrhage/Bleeding 146 146
Discomfort 144 144
Swelling 142 142
Failure of Implant 135 135
Numbness 134 134
Swelling/ Edema 113 113
Cardiac Perforation 105 105
Distress 100 100
Embolus 95 95
Emotional Changes 93 93
Ambulation Difficulties 92 92
Unspecified Tissue Injury 85 84
Bowel Perforation 81 81
Fatigue 63 63
Hematoma 54 54
Thromboembolism 53 53
Unspecified Mental, Emotional or Behavioural Problem 46 46
Disability 44 44
Cognitive Changes 39 39
Nausea 39 39
Sleep Dysfunction 37 37
Embolism 36 36
Blood Loss 34 34
Embolism/Embolus 34 34
Pericardial Effusion 33 33
Vascular System (Circulation), Impaired 31 31
Peripheral Edema 30 30
Dizziness 30 30
Stroke/CVA 28 28
Headache 27 27
Loss of Vision 26 26
Edema 25 25
Cramp(s) /Muscle Spasm(s) 23 23
Abdominal Cramps 22 22
Scar Tissue 22 22
Foreign Body Embolism 21 21
Myocardial Infarction 20 20
Unspecified Infection 20 20
High Blood Pressure/ Hypertension 19 19
Cardiac Tamponade 19 19
Low Blood Pressure/ Hypotension 17 17
Inflammation 15 15
Erosion 15 15
Muscle Weakness 15 15
Pseudoaneurysm 15 15
Patient Problem/Medical Problem 14 14
Calcium Deposits/Calcification 14 14
Tachycardia 13 13
Hematuria 13 13
Weight Changes 12 12
Transient Ischemic Attack 12 12
Cardiac Arrest 12 12
Extravasation 12 12
Neuropathy 11 11
Nerve Damage 10 10
Memory Loss/Impairment 10 10
Scarring 10 10
Cramp(s) 10 10
Weakness 10 10
Sexual Dysfunction 10 10
Vomiting 9 9
Visual Impairment 9 9
Renal Failure 9 9
Aneurysm 9 9
Atrial Fibrillation 8 8
Bone Fracture(s) 8 8
Ulcer 8 8
Unspecified Eye / Vision Problem 8 8
Syncope/Fainting 8 8
Chest Tightness/Pressure 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Argon Medical Devices, Inc II Jul-27-2023
2 Cook Medical Incorporated III Apr-06-2022
3 Cook Medical Incorporated III Mar-19-2019
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