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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device microspheres radionuclide
Definition Approved PMA: P990065
Product CodeNAW
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023 2024
0 0 0 3 2 3 4

MDR Year MDR Reports MDR Events
2018 48 48
2019 60 60
2020 28 28
2021 76 76
2022 23 23
2023 37 37
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 256 256
Insufficient Information 7 7
Patient-Device Incompatibility 3 3
Detachment of Device or Device Component 2 2
Device Operates Differently Than Expected 2 2
Physical Resistance/Sticking 2 2
Malposition of Device 2 2
Infusion or Flow Problem 2 2
Radiation Underexposure 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Contamination with Chemical or Other Material 1 1
Backflow 1 1
Material Fragmentation 1 1
Labelling, Instructions for Use or Training Problem 1 1
Loose or Intermittent Connection 1 1
Use of Device Problem 1 1
Inaccurate Delivery 1 1
Obstruction of Flow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Ascites 54 54
Liver Damage/Dysfunction 52 52
Abdominal Pain 44 44
Death 44 44
Inflammation 35 35
Unintended Radiation Exposure 33 33
Dyspnea 27 27
Fever 25 25
Hyperbilirubinemia 23 23
No Code Available 20 20
Encephalopathy 19 19
Pain 19 19
No Clinical Signs, Symptoms or Conditions 18 18
Fatigue 17 17
Hemorrhage/Bleeding 15 15
Nausea 15 15
Ulcer 15 15
Vomiting 13 13
Abscess 13 13
Test Result 12 12
Unspecified Infection 11 11
Renal Failure 11 11
Sepsis 10 10
Necrosis 9 9
Jaundice 8 8
Pleural Effusion 7 7
Liver Failure 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Decreased Appetite 6 6
Pneumonia 6 6
Muscle Weakness 6 6
Diarrhea 6 6
Hepatitis 5 5
Swelling/ Edema 5 5
Radiation Exposure, Unintended 5 5
Low White Blood Cell Count 4 4
Thrombosis/Thrombus 4 4
Internal Organ Perforation 4 4
No Known Impact Or Consequence To Patient 4 4
Insufficient Information 4 4
Edema 4 4
Anemia 4 4
Dysphagia/ Odynophagia 3 3
High Blood Pressure/ Hypertension 3 3
Fistula 3 3
Rash 3 3
Chills 3 3
Radiation Sickness Syndrome 3 3
Stenosis 3 3
Cognitive Changes 3 3
Malaise 3 3
Constipation 3 3
Thrombocytopenia 3 3
Weight Changes 3 3
Abdominal Distention 3 3
Pseudoaneurysm 2 2
Blood Loss 2 2
Patient Problem/Medical Problem 2 2
Cough 2 2
Pancreatitis 2 2
Vascular Dissection 2 2
Laceration(s) of Esophagus 2 2
Confusion/ Disorientation 2 2
Weakness 2 2
Septic Shock 2 2
Chest Pain 2 2
Gastritis 2 2
Hematoma 2 2
Bacterial Infection 2 2
Cardiac Arrest 2 2
Cellulitis 1 1
Biliary Cirrhosis 1 1
Anaphylactic Shock 1 1
Pulmonary Embolism 1 1
Radiation Overdose 1 1
Dehydration 1 1
Erythema 1 1
Fall 1 1
Hemoptysis 1 1
Hiccups 1 1
Low Blood Pressure/ Hypotension 1 1
Hyperglycemia 1 1
Hair Loss 1 1
Hearing Impairment 1 1
Pyrosis/Heartburn 1 1
Foreign Body Reaction 1 1
Seroma 1 1
Shock 1 1
Swelling 1 1
Swollen Lymph Nodes 1 1
Tachycardia 1 1
Thrombosis 1 1
Thrombus 1 1
Thyroid Problems 1 1
Tissue Damage 1 1
Ulceration 1 1
Urinary Tract Infection 1 1
Local Reaction 1 1
Neurological Deficit/Dysfunction 1 1
Rupture 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Aug-19-2021
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