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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device filter, intravascular, cardiovascular
Product CodeDTK
Regulation Number 870.3375
Device Class 2


Premarket Reviews
ManufacturerDecision
ALN S.A.R.L.
  SUBSTANTIALLY EQUIVALENT 1
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 229 229

Device Problems MDRs with this Device Problem Events in those MDRs
Structural Problem 4686 4686
Insufficient Information 4030 4030
Appropriate Term/Code Not Available 4013 4013
Difficult to Remove 2953 2961
Device Tipped Over 2412 2412
Malposition of Device 2218 2270
Unintended Movement 2011 2010
Patient Device Interaction Problem 1879 1932
Detachment of Device or Device Component 1769 1779
Adverse Event Without Identified Device or Use Problem 1468 1468
Obstruction of Flow 1321 1321
Fracture 1299 1299
Patient-Device Incompatibility 1269 1370
Migration or Expulsion of Device 1010 1013
Migration 989 991
Failure to Align 974 974
Positioning Problem 588 590
Inadequate Filtration Process 324 324
Entrapment of Device 288 288
Activation Failure 285 285
Material Deformation 283 285
Failure to Advance 138 138
Therapeutic or Diagnostic Output Failure 123 123
Break 110 110
Difficult or Delayed Activation 106 106
Activation, Positioning or Separation Problem 94 94
Improper or Incorrect Procedure or Method 91 91
Material Perforation 86 86
Material Twisted/Bent 76 76
Difficult to Advance 56 56
Material Puncture/Hole 53 53
Defective Device 49 49
Activation Problem 49 49
Premature Activation 42 42
Deformation Due to Compressive Stress 38 38
Device Dislodged or Dislocated 37 37
Difficult to Insert 36 36
Physical Resistance/Sticking 34 34
Positioning Failure 27 27
Defective Component 25 25
Retraction Problem 24 24
Difficult to Open or Close 21 21
Output Problem 21 21
Failure to Unfold or Unwrap 18 18
Complete Blockage 16 16
Material Split, Cut or Torn 16 16
Material Separation 15 15
Difficult or Delayed Positioning 12 12
Material Fragmentation 11 11
Unexpected Therapeutic Results 11 11
Difficult or Delayed Separation 11 11
Material Protrusion/Extrusion 10 10
Device Misassembled During Manufacturing /Shipping 10 10
Off-Label Use 10 10
Device Contamination with Chemical or Other Material 9 9
Sharp Edges 8 8
Material Frayed 8 8
Coagulation in Device or Device Ingredient 8 8
Partial Blockage 8 8
Loss of or Failure to Bond 8 8
Device-Device Incompatibility 7 7
Connection Problem 6 6
No Apparent Adverse Event 6 6
Crack 6 6
Difficult to Fold, Unfold or Collapse 6 6
Component Incompatible 5 5
Collapse 5 5
Therapy Delivered to Incorrect Body Area 5 5
Component Missing 4 4
Tear, Rip or Hole in Device Packaging 4 4
Misassembled 4 4
Mechanical Jam 4 4
Device Damaged by Another Device 3 3
Missing Information 3 3
Peeled/Delaminated 3 3
Disconnection 3 3
Inadequacy of Device Shape and/or Size 3 3
Use of Device Problem 3 3
Unraveled Material 2 2
Fitting Problem 2 2
Loose or Intermittent Connection 2 2
Mechanical Problem 2 2
Poor Quality Image 2 2
Nonstandard Device 2 2
Contamination 2 2
Material Erosion 2 2
Premature Separation 2 2
Separation Problem 2 2
Difficult to Open or Remove Packaging Material 2 2
Impedance Problem 2 2
Expulsion 1 1
Device Markings/Labelling Problem 1 1
Mechanics Altered 1 1
Material Integrity Problem 1 1
Packaging Problem 1 1
Device Handling Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Incomplete or Inadequate Connection 1 1
Ejection Problem 1 1
Firing Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Perforation of Vessels 7473 7473
No Information 4210 4210
Internal Organ Perforation 3925 3925
Perforation 2166 2166
Pain 2099 2099
No Clinical Signs, Symptoms or Conditions 1914 2086
Anxiety 1803 1803
Insufficient Information 1709 1709
No Consequences Or Impact To Patient 1570 1577
Pulmonary Embolism 1413 1414
Abdominal Pain 1298 1298
Thrombosis 1094 1094
Thrombosis/Thrombus 932 932
Vessel Or Plaque, Device Embedded In 925 925
Device Embedded In Tissue or Plaque 824 824
Depression 691 691
Stenosis 677 677
Occlusion 652 652
Coagulation Disorder 522 522
Dyspnea 480 480
Chest Pain 478 478
No Code Available 419 419
Thrombus 394 394
Obstruction/Occlusion 327 327
Injury 301 301
No Known Impact Or Consequence To Patient 289 289
Great Vessel Perforation 280 280
Death 258 258
Foreign Body In Patient 194 194
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 153 153
Hemorrhage/Bleeding 147 147
Discomfort 145 145
Swelling 142 142
Failure of Implant 137 137
Numbness 134 134
Swelling/ Edema 113 113
Cardiac Perforation 105 105
Distress 101 101
Ambulation Difficulties 95 95
Embolus 95 95
Emotional Changes 93 93
Unspecified Tissue Injury 85 84
Bowel Perforation 81 81
Fatigue 63 63
Thromboembolism 55 55
Hematoma 54 54
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
Foreign Body Embolism 22 22
Abdominal Cramps 22 22
Scar Tissue 22 22
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
Tachycardia 15 15
Pseudoaneurysm 15 15
Patient Problem/Medical Problem 14 14
Calcium Deposits/Calcification 14 14
Cardiac Arrest 13 13
Hematuria 13 13
Weight Changes 12 12
Extravasation 12 12
Transient Ischemic Attack 12 12
Neuropathy 11 11
Nerve Damage 10 10
Memory Loss/Impairment 10 10
Scarring 10 10
Weakness 10 10
Cramp(s) 10 10
Syncope/Fainting 10 10
Sexual Dysfunction 10 10
Visual Impairment 9 9
Vomiting 9 9
Renal Failure 9 9
Aneurysm 9 9
Atrial Fibrillation 8 8
Bone Fracture(s) 8 8
Unspecified Eye / Vision Problem 8 8
Ulcer 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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