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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)
2020 2021 2022 2023 2024 2025
0 3 2 3 5 3

MDR Year MDR Reports MDR Events
2020 28 28
2021 76 76
2022 23 23
2023 37 37
2024 53 53
2025 74 74

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 269 269
Radiation Underexposure 4 4
Insufficient Information 4 4
Device Contamination with Chemical or Other Material 4 4
Detachment of Device or Device Component 2 2
Leak/Splash 1 1
Device Contaminated During Manufacture or Shipping 1 1
Malposition of Device 1 1
Physical Resistance/Sticking 1 1
Therapeutic or Diagnostic Output Failure 1 1
Air/Gas in Device 1 1
Contamination 1 1
Use of Device Problem 1 1
Backflow 1 1
Improper Flow or Infusion 1 1
Infusion or Flow Problem 1 1
Labelling, Instructions for Use or Training Problem 1 1
Migration 1 1
Inaccurate Delivery 1 1
Connection Problem 1 1
Loose or Intermittent Connection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Abdominal Pain 75 75
Ascites 54 54
Nausea 51 51
Liver Damage/Dysfunction 50 50
Unintended Radiation Exposure 41 41
Inflammation 37 37
Fatigue 35 35
Fever 31 31
Pain 30 30
No Clinical Signs, Symptoms or Conditions 30 30
Dyspnea 28 28
Hemorrhage/Bleeding 20 20
Low White Blood Cell Count 20 20
Hyperbilirubinemia 20 20
Vomiting 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Decreased Appetite 16 16
Constipation 15 15
Encephalopathy 13 13
Ulcer 12 12
Muscle Weakness 11 11
Unspecified Infection 11 11
Pleural Effusion 11 11
Swelling/ Edema 10 10
Cough 10 10
Pneumonia 10 10
Abscess 10 10
Anemia 9 9
Necrosis 8 8
Thrombocytopenia 8 8
Liver Failure 8 8
Jaundice 8 8
Bacterial Infection 7 7
Weight Changes 7 7
Chills 6 6
Insufficient Information 6 6
Death 5 5
Malaise 5 5
Confusion/ Disorientation 5 5
Thrombosis/Thrombus 5 5
Discomfort 5 5
Sepsis 4 4
Pseudoaneurysm 4 4
Abdominal Distention 4 4
Renal Failure 4 4
High Blood Pressure/ Hypertension 4 4
Diarrhea 4 4
Fistula 3 3
Stenosis 3 3
Radiation Sickness Syndrome 3 3

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