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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)
2019 2020 2021 2022 2023 2024
0 0 3 2 3 4

MDR Year MDR Reports MDR Events
2019 60 60
2020 28 28
2021 76 76
2022 23 23
2023 37 37
2024 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 229 229
Insufficient Information 5 5
Patient-Device Incompatibility 2 2
Physical Resistance/Sticking 2 2
Malposition of Device 2 2
Detachment of Device or Device Component 2 2
Radiation Underexposure 1 1
Therapeutic or Diagnostic Output Failure 1 1
Infusion or Flow Problem 1 1
Inaccurate Delivery 1 1
Loose or Intermittent Connection 1 1
Use of Device Problem 1 1
Backflow 1 1
Obstruction of Flow 1 1
Device Contamination with Chemical or Other Material 1 1
Labelling, Instructions for Use or Training Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Ascites 53 53
Abdominal Pain 44 44
Liver Damage/Dysfunction 40 40
Unintended Radiation Exposure 34 34
Inflammation 32 32
Dyspnea 29 29
Death 24 24
Fever 23 23
Fatigue 20 20
Nausea 19 19
No Clinical Signs, Symptoms or Conditions 18 18
Pain 17 17
Hyperbilirubinemia 17 17
Hemorrhage/Bleeding 16 16
Encephalopathy 12 12
Vomiting 12 12
Abscess 12 12
No Code Available 12 12
Test Result 12 12
Ulcer 11 11
Necrosis 9 9
Jaundice 8 8
Unspecified Infection 8 8
Renal Failure 8 8
Sepsis 8 8
Muscle Weakness 8 8
Pleural Effusion 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Liver Failure 7 7
Decreased Appetite 7 7
Low White Blood Cell Count 6 6
Swelling/ Edema 6 6
Pneumonia 6 6
Weight Changes 6 6
Cough 5 5
Confusion/ Disorientation 5 5
Chills 5 5
Diarrhea 5 5
Thrombocytopenia 4 4
Bacterial Infection 4 4
Edema 4 4
Hepatitis 4 4
Insufficient Information 4 4
Thrombosis/Thrombus 4 4
Malaise 3 3
Stenosis 3 3
Anemia 3 3
Dysphagia/ Odynophagia 3 3
Radiation Sickness Syndrome 3 3
Fistula 3 3

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