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Device
microspheres radionuclide
Definition
Approved PMA: P990065
Product Code
NAW
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
7
7
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
215
215
Insufficient Information
4
4
Physical Resistance/Sticking
2
2
Malposition of Device
2
2
Patient-Device Incompatibility
2
2
Detachment of Device or Device Component
2
2
Device Contamination with Chemical or Other Material
1
1
Infusion or Flow Problem
1
1
Backflow
1
1
Labelling, Instructions for Use or Training Problem
1
1
Loose or Intermittent Connection
1
1
Use of Device Problem
1
1
Inaccurate Delivery
1
1
Obstruction of Flow
1
1
Radiation Underexposure
1
1
Therapeutic or Diagnostic Output Failure
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Ascites
51
51
Abdominal Pain
40
40
Liver Damage/Dysfunction
37
37
Unintended Radiation Exposure
33
33
Inflammation
32
32
Dyspnea
26
26
Death
24
24
Fever
21
21
No Clinical Signs, Symptoms or Conditions
18
18
Fatigue
17
17
Hyperbilirubinemia
16
16
Pain
16
16
Hemorrhage/Bleeding
14
14
Nausea
14
14
Encephalopathy
12
12
Abscess
12
12
Test Result
12
12
No Code Available
12
12
Ulcer
11
11
Vomiting
11
11
Necrosis
9
9
Unspecified Infection
8
8
Jaundice
8
8
Renal Failure
8
8
Sepsis
8
8
Pleural Effusion
7
7
Liver Failure
7
7
Decreased Appetite
6
6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
6
6
Muscle Weakness
6
6
Diarrhea
5
5
Swelling/ Edema
5
5
Insufficient Information
4
4
Low White Blood Cell Count
4
4
Thrombosis/Thrombus
4
4
Edema
4
4
Hepatitis
4
4
Pneumonia
4
4
Rash
3
3
Chills
3
3
Radiation Sickness Syndrome
3
3
Stenosis
3
3
Malaise
3
3
Dysphagia/ Odynophagia
3
3
Fistula
3
3
Anemia
3
3
Thrombocytopenia
3
3
Constipation
2
2
Cough
2
2
Pancreatitis
2
2
Bacterial Infection
2
2
Cardiac Arrest
2
2
High Blood Pressure/ Hypertension
2
2
Hematoma
2
2
Laceration(s) of Esophagus
2
2
Vascular Dissection
2
2
Cognitive Changes
2
2
Confusion/ Disorientation
2
2
Abdominal Distention
2
2
Pseudoaneurysm
2
2
Weight Changes
2
2
Patient Problem/Medical Problem
2
2
Weakness
2
2
Septic Shock
2
2
Seroma
1
1
Shock
1
1
Swollen Lymph Nodes
1
1
Tachycardia
1
1
Thrombosis
1
1
Tissue Damage
1
1
Urinary Tract Infection
1
1
Rupture
1
1
Local Reaction
1
1
Nervous System Injury
1
1
No Known Impact Or Consequence To Patient
1
1
Fibrosis
1
1
Fungal Infection
1
1
Respiratory Tract Infection
1
1
Obstruction/Occlusion
1
1
Respiratory Failure
1
1
Underdose
1
1
Discomfort
1
1
Hemoptysis
1
1
Fall
1
1
Hiccups
1
1
Neurological Deficit/Dysfunction
1
1
Internal Organ Perforation
1
1
Chest Pain
1
1
Biliary Cirrhosis
1
1
Anaphylactic Shock
1
1
Pulmonary Embolism
1
1
Radiation Overdose
1
1
Foreign Body Reaction
1
1
Hair Loss
1
1
Hearing Impairment
1
1
Pyrosis/Heartburn
1
1
Stomach Ulceration
1
1
Alteration in Body Temperature
1
1
Unspecified Hepatic or Biliary Problem
1
1
Unspecified Kidney or Urinary Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific Corporation
II
Aug-19-2021
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