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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)
2021 2022 2023 2024 2025 2026
3 2 3 5 3 0

MDR Year MDR Reports MDR Events
2021 76 76
2022 23 23
2023 37 37
2024 53 53
2025 77 77

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 246 246
Radiation Underexposure 4 4
Insufficient Information 4 4
Device Contamination with Chemical or Other Material 4 4
Contamination 2 2
Leak/Splash 1 1
Device Contaminated During Manufacture or Shipping 1 1
Physical Resistance/Sticking 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Air/Gas in Device 1 1
Backflow 1 1
Use of Device Problem 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 70 70
Nausea 50 50
Liver Damage/Dysfunction 46 46
Ascites 43 43
Unintended Radiation Exposure 41 41
Inflammation 36 36
Fatigue 31 31
No Clinical Signs, Symptoms or Conditions 28 28
Pain 28 28
Dyspnea 28 28
Fever 28 28
Low White Blood Cell Count 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 19 19
Vomiting 19 19
Decreased Appetite 16 16
Hemorrhage/Bleeding 16 16
Hyperbilirubinemia 16 16
Constipation 16 16
Ulcer 12 12
Muscle Weakness 12 12
Unspecified Infection 11 11
Swelling/ Edema 10 10
Cough 10 10
Pneumonia 9 9
Pleural Effusion 9 9
Anemia 9 9
Thrombocytopenia 8 8
Abscess 8 8
Necrosis 8 8
Encephalopathy 7 7
Bacterial Infection 7 7
Liver Failure 7 7
Insufficient Information 7 7
Weight Changes 6 6
Chills 6 6
Jaundice 6 6
Thrombosis/Thrombus 5 5
Discomfort 5 5
Malaise 5 5
Pyrosis/Heartburn 4 4
Pseudoaneurysm 4 4
High Blood Pressure/ Hypertension 4 4
Abdominal Distention 4 4
Renal Failure 4 4
Sepsis 4 4
Stenosis 3 3
Fistula 3 3
Flatus 3 3
Diarrhea 3 3
Chest Pain 3 3

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