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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 1

MDR Year MDR Reports MDR Events
2017 37 37
2018 48 48
2019 60 60
2020 28 28
2021 76 76
2022 18 18

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 240 240
Insufficient Information 8 8
Device Operates Differently Than Expected 4 4
Use of Device Problem 4 4
Patient-Device Incompatibility 4 4
Detachment of Device or Device Component 2 2
Malposition of Device 2 2
Infusion or Flow Problem 2 2
Physical Resistance/Sticking 2 2
Radiation Underexposure 1 1
Therapeutic or Diagnostic Output Failure 1 1
Device Contamination with Chemical or Other Material 1 1
Inaccurate Delivery 1 1
Obstruction of Flow 1 1
Backflow 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
Liver Damage/Dysfunction 64 64
Death 63 63
Ascites 54 54
Abdominal Pain 46 46
Inflammation 32 32
Dyspnea 25 25
Hyperbilirubinemia 24 24
Encephalopathy 23 23
No Code Available 23 23
Fever 21 21
Fatigue 20 20
Unintended Radiation Exposure 20 20
Nausea 16 16
Ulcer 14 14
No Clinical Signs, Symptoms or Conditions 13 13
Vomiting 12 12
Test Result 12 12
Pain 12 12
Renal Failure 12 12
Hemorrhage/Bleeding 11 11
Abscess 10 10
Unspecified Infection 10 10
Jaundice 9 9
Radiation Exposure, Unintended 8 8
Liver Failure 7 7
Sepsis 7 7
Edema 7 7
Diarrhea 7 7
Hepatitis 7 7
Pneumonia 6 6
Pleural Effusion 5 5
Necrosis 5 5
Anemia 5 5
Swelling/ Edema 5 5
Abdominal Distention 5 5
Toxicity 4 4
Weight Changes 4 4
No Known Impact Or Consequence To Patient 4 4
Radiation Sickness Syndrome 4 4
Internal Organ Perforation 4 4
Therapeutic Response, Decreased 4 4
Low White Blood Cell Count 4 4
Decreased Appetite 4 4
Insufficient Information 4 4
Muscle Weakness 4 4
Rash 3 3
High Blood Pressure/ Hypertension 3 3
Gastritis 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Cancer 3 3
Constipation 3 3
Stenosis 3 3
Weakness 3 3
Pseudoaneurysm 3 3
Patient Problem/Medical Problem 3 3
Vascular Dissection 3 3
Cognitive Changes 3 3
Confusion/ Disorientation 2 2
Injury 2 2
Blood Loss 2 2
Discomfort 2 2
Malaise 2 2
Laceration(s) of Esophagus 2 2
Multiple Organ Failure 2 2
Pancreatitis 2 2
Chest Pain 2 2
Fall 2 2
Hematoma 2 2
Fistula 2 2
Dehydration 2 2
Radiation Overdose 2 2
Bacterial Infection 2 2
Biliary Cirrhosis 2 2
Cardiac Arrest 2 2
Hyperglycemia 2 2
Septic Shock 2 2
Tachycardia 2 2
Thrombosis 2 2
Tissue Damage 2 2
Ulceration 1 1
Respiratory Distress 1 1
Chills 1 1
Electrolyte Imbalance 1 1
Heart Failure 1 1
Rupture 1 1
Peritonitis 1 1
Thrombus 1 1
Thyroid Problems 1 1
Seroma 1 1
Shock 1 1
Swelling 1 1
Swollen Lymph Nodes 1 1
Hypoglycemia 1 1
Low Blood Pressure/ Hypotension 1 1
Hypoxia 1 1
Local Reaction 1 1
Neurological Deficit/Dysfunction 1 1
Cellulitis 1 1
Pulmonary Embolism 1 1
Anaphylactic Shock 1 1

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