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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device agent, occluding, vascular, permanent
Definition The device is a polymerizing agent intended for permanent occlusion of peripheral blood vessels.
Product CodePJQ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 2 4 2 7 3 3 7 6 5 0

MDR Year MDR Reports MDR Events
2015 6 6
2016 41 41
2017 69 69
2018 110 110
2019 162 162
2020 152 152
2021 161 161
2022 180 180
2023 154 154
2024 23 23

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 564 564
Biocompatibility 378 378
Patient-Device Incompatibility 74 74
Migration or Expulsion of Device 17 17
Detachment of Device or Device Component 14 14
Defective Device 11 11
Activation, Positioning or Separation Problem 10 10
Obstruction of Flow 8 8
Use of Device Problem 7 7
Difficult to Remove 6 6
Material Deformation 6 6
Compatibility Problem 5 5
Deformation Due to Compressive Stress 3 3
Improper or Incorrect Procedure or Method 3 3
Migration 3 3
Physical Resistance/Sticking 2 2
Positioning Problem 2 2
Device Difficult to Setup or Prepare 2 2
Off-Label Use 2 2
Material Puncture/Hole 2 2
Difficult to Insert 2 2
Partial Blockage 2 2
Complete Blockage 2 2
Device Contamination with Chemical or Other Material 2 2
Device Operates Differently Than Expected 2 2
Difficult to Advance 2 2
Device Dislodged or Dislocated 1 1
Device Damaged by Another Device 1 1
Infusion or Flow Problem 1 1
Stretched 1 1
Misfire 1 1
Contamination 1 1
Fracture 1 1
Break 1 1
Mechanical Problem 1 1
Occlusion Within Device 1 1
Therapy Delivered to Incorrect Body Area 1 1
Defective Component 1 1
Failure to Deliver 1 1
Protective Measures Problem 1 1
Torn Material 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 1 1
Material Integrity Problem 1 1
Material Protrusion/Extrusion 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 248 248
Pain 184 184
Patient Problem/Medical Problem 146 146
Thrombosis/Thrombus 126 126
Phlebitis 107 107
Unspecified Infection 107 107
Reaction 91 91
Rash 89 89
Itching Sensation 87 87
Swelling/ Edema 81 81
Local Reaction 77 77
Inflammation 68 68
Thrombus 67 67
Erythema 51 51
Pulmonary Embolism 46 46
Foreign Body Reaction 45 45
Granuloma 45 45
Swelling 37 37
No Consequences Or Impact To Patient 34 34
Thrombosis 32 32
No Clinical Signs, Symptoms or Conditions 26 26
Ulcer 23 23
Skin Irritation 23 23
Fever 22 22
Cellulitis 21 21
Injury 19 19
Urticaria 18 18
Skin Inflammation/ Irritation 17 17
Insufficient Information 17 17
Abscess 16 16
Skin Inflammation 13 13
Dyspnea 12 12
Skin Discoloration 12 12
Purulent Discharge 9 9
Ecchymosis 9 9
Bruise/Contusion 8 8
Stroke/CVA 8 8
Hematoma 8 8
Ulceration 8 8
Discomfort 8 8
Numbness 7 7
Sepsis 7 7
Death 7 7
Edema 7 7
Irritation 6 6
Unspecified Tissue Injury 6 6
Thromboembolism 5 5
Foreign Body In Patient 5 5
No Code Available 5 5
Burning Sensation 5 5
Dizziness 4 4
Septic Shock 4 4
Occlusion 4 4
Necrosis 4 4
Bacterial Infection 4 4
Paresthesia 4 4
Embolism/Embolus 4 4
Obstruction/Occlusion 4 4
Blood Loss 3 3
No Known Impact Or Consequence To Patient 3 3
Nodule 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Anaphylactic Shock 3 3
Extravasation 3 3
Nerve Damage 3 3
Perforation 3 3
Pneumonia 3 3
Tachycardia 3 3
Chills 2 2
Rupture 2 2
Peeling 2 2
Fistula 2 2
Hair Loss 2 2
Low Blood Pressure/ Hypotension 2 2
Hemorrhage/Bleeding 2 2
Chest Pain 2 2
Cyanosis 1 1
Cyst(s) 1 1
Arrhythmia 1 1
Atrial Fibrillation 1 1
Autoimmune Disorder 1 1
Burn(s) 1 1
Embolism 1 1
Embolus 1 1
High Blood Pressure/ Hypertension 1 1
Failure of Implant 1 1
Headache 1 1
Fatigue 1 1
Neuropathy 1 1
Muscle Weakness 1 1
Pulmonary Infarction 1 1
Hot Flashes/Flushes 1 1
Tingling 1 1
Transient Ischemic Attack 1 1
Vasoconstriction 1 1
Visual Impairment 1 1
Vomiting 1 1
Peripheral Edema 1 1
Valvular Insufficiency/ Regurgitation 1 1
Unspecified Respiratory Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Covidien LLC II May-12-2015
2 Medtronic Inc. III May-12-2021
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