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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)
2019 2020 2021 2022 2023 2024
0 0 3 2 3 4

MDR Year MDR Reports MDR Events
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 215 215
Insufficient Information 4 4
Physical Resistance/Sticking 2 2
Malposition of Device 2 2
Patient-Device Incompatibility 2 2
Detachment of Device or Device Component 2 2
Device Contamination with Chemical or Other Material 1 1
Infusion or Flow Problem 1 1
Backflow 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
Radiation Underexposure 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Ascites 51 51
Abdominal Pain 40 40
Liver Damage/Dysfunction 37 37
Unintended Radiation Exposure 33 33
Inflammation 32 32
Dyspnea 26 26
Death 24 24
Fever 21 21
No Clinical Signs, Symptoms or Conditions 18 18
Fatigue 17 17
Hyperbilirubinemia 16 16
Pain 16 16
Hemorrhage/Bleeding 14 14
Nausea 14 14
Encephalopathy 12 12
Abscess 12 12
Test Result 12 12
No Code Available 12 12
Ulcer 11 11
Vomiting 11 11
Necrosis 9 9
Unspecified Infection 8 8
Jaundice 8 8
Renal Failure 8 8
Sepsis 8 8
Pleural Effusion 7 7
Liver Failure 7 7
Decreased Appetite 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Muscle Weakness 6 6
Diarrhea 5 5
Swelling/ Edema 5 5
Insufficient Information 4 4
Low White Blood Cell Count 4 4
Thrombosis/Thrombus 4 4
Edema 4 4
Hepatitis 4 4
Pneumonia 4 4
Rash 3 3
Chills 3 3
Radiation Sickness Syndrome 3 3
Stenosis 3 3
Malaise 3 3
Dysphagia/ Odynophagia 3 3
Fistula 3 3
Anemia 3 3
Thrombocytopenia 3 3
Constipation 2 2
Cough 2 2
Pancreatitis 2 2
Bacterial Infection 2 2
Cardiac Arrest 2 2
High Blood Pressure/ Hypertension 2 2
Hematoma 2 2
Laceration(s) of Esophagus 2 2
Vascular Dissection 2 2
Cognitive Changes 2 2
Confusion/ Disorientation 2 2
Abdominal Distention 2 2
Pseudoaneurysm 2 2
Weight Changes 2 2
Patient Problem/Medical Problem 2 2
Weakness 2 2
Septic Shock 2 2
Seroma 1 1
Shock 1 1
Swollen Lymph Nodes 1 1
Tachycardia 1 1
Thrombosis 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1
Rupture 1 1
Local Reaction 1 1
Nervous System Injury 1 1
No Known Impact Or Consequence To Patient 1 1
Fibrosis 1 1
Fungal Infection 1 1
Respiratory Tract Infection 1 1
Obstruction/Occlusion 1 1
Respiratory Failure 1 1
Underdose 1 1
Discomfort 1 1
Hemoptysis 1 1
Fall 1 1
Hiccups 1 1
Neurological Deficit/Dysfunction 1 1
Internal Organ Perforation 1 1
Chest Pain 1 1
Biliary Cirrhosis 1 1
Anaphylactic Shock 1 1
Pulmonary Embolism 1 1
Radiation Overdose 1 1
Foreign Body Reaction 1 1
Hair Loss 1 1
Hearing Impairment 1 1
Pyrosis/Heartburn 1 1
Stomach Ulceration 1 1
Alteration in Body Temperature 1 1
Unspecified Hepatic or Biliary Problem 1 1
Unspecified Kidney or Urinary Problem 1 1

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