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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)
2019 2020 2021 2022 2023 2024
3 3 7 6 5 2

MDR Year MDR Reports MDR Events
2019 162 162
2020 152 152
2021 161 161
2022 180 180
2023 154 154
2024 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Biocompatibility 392 392
Adverse Event Without Identified Device or Use Problem 380 380
Patient-Device Incompatibility 68 68
Detachment of Device or Device Component 13 13
Migration or Expulsion of Device 13 13
Activation, Positioning or Separation Problem 10 10
Defective Device 9 9
Use of Device Problem 7 7
Difficult to Remove 6 6
Obstruction of Flow 6 6
Compatibility Problem 5 5
Material Deformation 3 3
Migration 3 3
Physical Resistance/Sticking 2 2
Device Contamination with Chemical or Other Material 2 2
Difficult to Advance 2 2
Difficult to Insert 2 2
Improper or Incorrect Procedure or Method 2 2
Complete Blockage 2 2
Contamination 1 1
Fracture 1 1
Device Difficult to Setup or Prepare 1 1
Off-Label Use 1 1
Defective Component 1 1
Deformation Due to Compressive Stress 1 1
Device Damaged by Another Device 1 1
Device Dislodged or Dislocated 1 1
Infusion or Flow Problem 1 1
Positioning Problem 1 1
No Apparent Adverse Event 1 1
Insufficient Information 1 1
Material Integrity Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Hypersensitivity/Allergic reaction 234 234
Pain 159 159
Thrombosis/Thrombus 131 131
Unspecified Infection 94 94
Swelling/ Edema 87 87
Rash 86 86
Itching Sensation 84 84
Patient Problem/Medical Problem 84 84
Phlebitis 83 83
Local Reaction 76 76
Inflammation 54 54
Erythema 53 53
Reaction 48 48
Granuloma 44 44
Foreign Body Reaction 42 42
Pulmonary Embolism 36 36
Thrombus 35 35
No Clinical Signs, Symptoms or Conditions 27 27
Swelling 24 24
Ulcer 23 23
Fever 21 21
No Consequences Or Impact To Patient 20 20
Cellulitis 19 19
Injury 19 19
Skin Inflammation/ Irritation 19 19
Urticaria 18 18
Thrombosis 18 18
Abscess 17 17
Insufficient Information 17 17
Skin Irritation 15 15
Dyspnea 12 12
Skin Discoloration 11 11
Skin Inflammation 11 11
Ecchymosis 9 9
Purulent Discharge 9 9
Hematoma 7 7
Discomfort 7 7
Unspecified Tissue Injury 7 7
Ulceration 6 6
Bruise/Contusion 6 6
Stroke/CVA 6 6
Edema 5 5
Sepsis 5 5
Thromboembolism 5 5
Numbness 4 4
Obstruction/Occlusion 4 4
Dizziness 4 4
Embolism/Embolus 4 4
Paresthesia 4 4
Septic Shock 4 4
Necrosis 4 4
Burning Sensation 4 4
Bacterial Infection 4 4
Death 4 4
Irritation 4 4
Hemorrhage/Bleeding 3 3
Extravasation 3 3
Anaphylactic Shock 3 3
Nerve Damage 3 3
Occlusion 3 3
Perforation 3 3
Foreign Body In Patient 3 3
Nodule 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Blood Loss 3 3
No Code Available 2 2
Peeling 2 2
Pneumonia 2 2
Chills 2 2
Vasoconstriction 2 2
Tachycardia 2 2
Chest Pain 2 2
Fistula 2 2
Hair Loss 2 2
Low Blood Pressure/ Hypotension 2 2
Failure of Implant 1 1
High Blood Pressure/ Hypertension 1 1
Fatigue 1 1
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
Transient Ischemic Attack 1 1
Visual Impairment 1 1
Vomiting 1 1
Hot Flashes/Flushes 1 1
Rupture 1 1
Anaphylactoid 1 1
Scar Tissue 1 1
Neuropathy 1 1
Muscle Weakness 1 1
Unspecified Nervous System Problem 1 1
Swollen Lymph Nodes/Glands 1 1
Valvular Insufficiency/ Regurgitation 1 1
Unspecified Respiratory Problem 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Peripheral Edema 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc. III May-12-2021
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