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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)
2017 2018 2019 2020 2021 2022
2 0 0 0 3 0

MDR Year MDR Reports MDR Events
2017 37 37
2018 48 48
2019 60 60
2020 28 28
2021 76 76

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 224 224
Insufficient Information 8 8
Use of Device Problem 4 4
Patient-Device Incompatibility 4 4
Device Operates Differently Than Expected 4 4
Detachment of Device or Device Component 2 2
Malposition of Device 2 2
Physical Resistance/Sticking 1 1
Therapeutic or Diagnostic Output Failure 1 1
Infusion or Flow Problem 1 1
Inaccurate Delivery 1 1
Obstruction of Flow 1 1
Material Fragmentation 1 1
Loose or Intermittent Connection 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 63 63
Liver Damage/Dysfunction 63 63
Ascites 52 52
Abdominal Pain 44 44
Inflammation 26 26
Hyperbilirubinemia 24 24
Encephalopathy 23 23
No Code Available 23 23
Dyspnea 21 21
Fatigue 19 19
Unintended Radiation Exposure 18 18
Fever 17 17
Nausea 16 16
Ulcer 14 14
Test Result 12 12
Renal Failure 12 12
Vomiting 12 12
Pain 11 11
No Clinical Signs, Symptoms or Conditions 11 11
Hemorrhage/Bleeding 10 10
Abscess 10 10
Unspecified Infection 9 9
Jaundice 9 9
Radiation Exposure, Unintended 8 8
Sepsis 7 7
Edema 7 7
Diarrhea 7 7
Hepatitis 7 7
Pneumonia 6 6
Abdominal Distention 5 5
Liver Failure 5 5
Swelling/ Edema 4 4
No Known Impact Or Consequence To Patient 4 4
Therapeutic Response, Decreased 4 4
Weight Changes 4 4
Toxicity 4 4
Internal Organ Perforation 4 4
Muscle Weakness 4 4
Anemia 4 4
Gastritis 3 3
Necrosis 3 3
High Blood Pressure/ Hypertension 3 3
Pleural Effusion 3 3
Rash 3 3
Weakness 3 3
Cognitive Changes 3 3
Radiation Sickness Syndrome 3 3
Stenosis 3 3
Patient Problem/Medical Problem 3 3
Pseudoaneurysm 3 3
Vascular Dissection 3 3
Cancer 3 3
Constipation 3 3
Decreased Appetite 3 3
Insufficient Information 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Low White Blood Cell Count 2 2
Pancreatitis 2 2
Multiple Organ Failure 2 2
Blood Loss 2 2
Discomfort 2 2
Confusion/ Disorientation 2 2
Injury 2 2
Malaise 2 2
Laceration(s) of Esophagus 2 2
Tissue Damage 2 2
Septic Shock 2 2
Tachycardia 2 2
Thrombosis 2 2
Hematoma 2 2
Fistula 2 2
Chest Pain 2 2
Fall 2 2
Biliary Cirrhosis 2 2
Cardiac Arrest 2 2
Radiation Overdose 2 2
Dehydration 2 2
Dysphagia/ Odynophagia 1 1
Embolism 1 1
Erythema 1 1
Pulmonary Embolism 1 1
Anaphylactic Shock 1 1
Cellulitis 1 1
Atrial Tachycardia 1 1
Hemorrhage, Cerebral 1 1
Intracranial Hemorrhage 1 1
Hiccups 1 1
Hyperglycemia 1 1
Foreign Body Reaction 1 1
Hair Loss 1 1
Hearing Impairment 1 1
Pyrosis/Heartburn 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Neurological Deficit/Dysfunction 1 1
Local Reaction 1 1
Respiratory Distress 1 1
Thrombus 1 1
Thyroid Problems 1 1
Seroma 1 1

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