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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 1

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

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 200 200
Insufficient Information 4 4
Radiation Underexposure 2 2
Detachment of Device or Device Component 2 2
Device Contamination with Chemical or Other Material 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
Backflow 1 1
Use of Device Problem 1 1
Infusion or Flow Problem 1 1
Labelling, Instructions for Use or Training Problem 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
Ascites 44 44
Abdominal Pain 40 40
Unintended Radiation Exposure 35 35
Inflammation 33 33
Liver Damage/Dysfunction 27 27
Dyspnea 26 26
Nausea 22 22
Fever 21 21
No Clinical Signs, Symptoms or Conditions 20 20
Pain 19 19
Fatigue 18 18
Hyperbilirubinemia 16 16
Hemorrhage/Bleeding 16 16
Vomiting 12 12
Encephalopathy 10 10
Ulcer 10 10
Abscess 9 9
Liver Failure 8 8
Unspecified Infection 8 8
Necrosis 8 8
Muscle Weakness 8 8
Swelling/ Edema 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Decreased Appetite 7 7
Low White Blood Cell Count 7 7
Pleural Effusion 7 7
Jaundice 7 7
Chills 6 6
Weight Changes 5 5
Death 5 5
Confusion/ Disorientation 5 5
Cough 5 5
Insufficient Information 4 4
Pneumonia 4 4
Thrombosis/Thrombus 4 4
Renal Failure 4 4
Thrombocytopenia 4 4
Constipation 4 4
Bacterial Infection 4 4
Sepsis 4 4
Stenosis 3 3
Obstruction/Occlusion 3 3
Test Result 3 3
Diarrhea 3 3
Fistula 3 3
Radiation Sickness Syndrome 3 3
Flatus 3 3
Dysphagia/ Odynophagia 2 2
Pseudoaneurysm 2 2
Loss of consciousness 2 2

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