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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)
2015 2016 2017 2018 2019 2020
1 0 2 0 0 0

MDR Year MDR Reports MDR Events
2015 33 33
2016 39 39
2017 37 37
2018 48 48
2019 60 60
2020 24 24

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 162 162
Insufficient Information 42 42
Patient-Device Incompatibility 9 9
Device Operates Differently Than Expected 7 7
Activation, Positioning or SeparationProblem 5 5
Improper or Incorrect Procedure or Method 5 5
Use of Device Problem 4 4
Malposition of Device 3 3
Therapy Delivered to Incorrect Body Area 2 2
Inaccurate Delivery 2 2
Appropriate Term/Code Not Available 2 2
Infusion or Flow Problem 1 1
Catheter 1 1
Delivery System Failure 1 1
Obstruction of Flow 1 1
Structural Problem 1 1
Failure to Align 1 1
Signal Artifact/Noise 1 1
Material Fragmentation 1 1
Inadequate Instructions for Healthcare Professional 1 1
Migration or Expulsion of Device 1 1
Premature Activation 1 1
Sticking 1 1
Unexpected Therapeutic Results 1 1
High Test Results 1 1
Radiation Underexposure 1 1
Stopcock Valve 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Death 82 82
Liver Damage/Dysfunction 77 78
Ascites 53 53
Abdominal Pain 35 37
No Code Available 30 32
Encephalopathy 24 24
Test Result 19 19
Hyperbilirubinemia 17 17
Fatigue 15 16
Fever 13 14
Hemorrhage/Bleeding 13 14
Vomiting 13 14
Nausea 12 12
Ulcer 11 12
Toxicity 10 10
Pain 10 11
Edema 9 9
Radiation Exposure, Unintended 9 9
Inflammation 9 9
Renal Failure 9 9
Hepatitis 8 8
No Known Impact Or Consequence To Patient 8 8
Sepsis 7 7
Weight Changes 7 7
Pneumonia 7 8
Weakness 6 6
Jaundice 6 6
Diarrhea 6 6
Dyspnea 6 6
Abscess 5 5
Cancer 5 5
Unspecified Infection 5 5
Therapeutic Response, Decreased 5 6
Patient Problem/Medical Problem 5 5
Constipation 4 4
Discomfort 4 4
Internal Organ Perforation 4 5
Tachycardia 4 4
Pleural Effusion 4 4
Abdominal Distention 4 4
Thrombosis 4 4
Dehydration 4 4
Swelling 4 4
Fall 3 3
Rash 3 3
Anemia 3 3
Gastritis 3 3
Cognitive Changes 3 3
Multiple Organ Failure 3 3
Necrosis 3 3
Radiation Overdose 3 3
Radiation Sickness Syndrome 3 3
Complaint, Ill-Defined 3 3
Injury 3 3
Fibrosis 3 3
Laceration(s) of Esophagus 2 2
Shaking/Tremors 2 2
Confusion/ Disorientation 2 2
Blood Loss 2 2
Chest Pain 2 2
Biliary Cirrhosis 2 2
Tissue Damage 2 2
Underdose 2 2
Malaise 2 2
Respiratory Failure 2 2
Occlusion 2 2
Radiation Underdose 2 2
Chills 2 2
Rupture 2 2
Peritonitis 2 2
Swollen Lymph Nodes 1 1
Septic Shock 1 1
Irritation 1 1
Muscle Weakness 1 1
Neurological Deficit/Dysfunction 1 1
Hearing Impairment 1 1
Hemorrhage, Cerebral 1 1
Intracranial Hemorrhage 1 1
Hiccups 1 1
High Blood Pressure/ Hypertension 1 1
Low Blood Pressure/ Hypotension 1 1
Hypovolemic Shock 1 1
Atrial Tachycardia 1 1
Congestive Heart Failure 1 1
Dysphagia/ Odynophagia 1 1
Erythema 1 1
Ischemic Heart Disease 1 1
Fungal Infection 1 1
Thrombus 1 1
Ulceration 1 1
Hip Fracture 1 1
Abdominal Cramps 1 1
Dysuria 1 1
Vascular Dissection 1 1
Urinary Retention 1 1
Thyroid Problems 1 1
Heart Failure 1 1
Brain Injury 1 1
Local Reaction 1 1
Respiratory Distress 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Biocompatibles U.K., Ltd. II Oct-13-2016
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