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TPLC
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Device
agent, occluding, vascular, permanent
Definition
The device is a polymerizing agent intended for permanent occlusion of peripheral blood vessels.
Product Code
PJQ
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
0
0
0
0
0
0
2
4
2
7
3
3
7
6
5
0
MDR Year
MDR Reports
MDR Events
2015
6
6
2016
41
41
2017
69
69
2018
110
110
2019
162
162
2020
152
152
2021
161
161
2022
180
180
2023
154
154
2024
33
33
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
569
569
Biocompatibility
383
383
Patient-Device Incompatibility
74
74
Migration or Expulsion of Device
17
17
Detachment of Device or Device Component
14
14
Defective Device
11
11
Activation, Positioning or Separation Problem
10
10
Obstruction of Flow
8
8
Use of Device Problem
7
7
Difficult to Remove
6
6
Material Deformation
6
6
Compatibility Problem
5
5
Deformation Due to Compressive Stress
3
3
Improper or Incorrect Procedure or Method
3
3
Migration
3
3
Physical Resistance/Sticking
2
2
Positioning Problem
2
2
Device Difficult to Setup or Prepare
2
2
Off-Label Use
2
2
Material Puncture/Hole
2
2
Difficult to Insert
2
2
Partial Blockage
2
2
Complete Blockage
2
2
Device Contamination with Chemical or Other Material
2
2
Device Operates Differently Than Expected
2
2
Difficult to Advance
2
2
Device Dislodged or Dislocated
1
1
Device Damaged by Another Device
1
1
Infusion or Flow Problem
1
1
Stretched
1
1
Misfire
1
1
Contamination
1
1
Fracture
1
1
Break
1
1
Mechanical Problem
1
1
Occlusion Within Device
1
1
Therapy Delivered to Incorrect Body Area
1
1
Defective Component
1
1
Failure to Deliver
1
1
Protective Measures Problem
1
1
Torn Material
1
1
No Apparent Adverse Event
1
1
Insufficient Information
1
1
Appropriate Term/Code Not Available
1
1
Device Handling Problem
1
1
Material Integrity Problem
1
1
Material Protrusion/Extrusion
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hypersensitivity/Allergic reaction
251
251
Pain
184
184
Patient Problem/Medical Problem
146
146
Thrombosis/Thrombus
130
130
Unspecified Infection
108
108
Phlebitis
107
107
Reaction
91
91
Rash
90
90
Itching Sensation
89
89
Swelling/ Edema
84
84
Local Reaction
77
77
Inflammation
69
69
Thrombus
67
67
Erythema
54
54
Pulmonary Embolism
46
46
Foreign Body Reaction
45
45
Granuloma
45
45
Swelling
37
37
No Consequences Or Impact To Patient
34
34
Thrombosis
32
32
No Clinical Signs, Symptoms or Conditions
26
26
Ulcer
23
23
Skin Irritation
23
23
Fever
23
23
Cellulitis
21
21
Injury
19
19
Urticaria
18
18
Abscess
18
18
Skin Inflammation/ Irritation
17
17
Insufficient Information
17
17
Skin Inflammation
13
13
Dyspnea
12
12
Skin Discoloration
12
12
Purulent Discharge
9
9
Ecchymosis
9
9
Bruise/Contusion
8
8
Stroke/CVA
8
8
Hematoma
8
8
Ulceration
8
8
Discomfort
8
8
Numbness
7
7
Sepsis
7
7
Death
7
7
Edema
7
7
Irritation
6
6
Unspecified Tissue Injury
6
6
Thromboembolism
5
5
Foreign Body In Patient
5
5
No Code Available
5
5
Bacterial Infection
5
5
Burning Sensation
5
5
Dizziness
4
4
Septic Shock
4
4
Occlusion
4
4
Necrosis
4
4
Paresthesia
4
4
Embolism/Embolus
4
4
Obstruction/Occlusion
4
4
Blood Loss
3
3
No Known Impact Or Consequence To Patient
3
3
Nodule
3
3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
3
3
Nerve Damage
3
3
Perforation
3
3
Pneumonia
3
3
Tachycardia
3
3
Anaphylactic Shock
3
3
Extravasation
3
3
Fistula
2
2
Hair Loss
2
2
Low Blood Pressure/ Hypotension
2
2
Hemorrhage/Bleeding
2
2
Chest Pain
2
2
Vasoconstriction
2
2
Chills
2
2
Rupture
2
2
Peeling
2
2
Neuropathy
1
1
Muscle Weakness
1
1
Pulmonary Infarction
1
1
Hot Flashes/Flushes
1
1
Tingling
1
1
Transient Ischemic Attack
1
1
Visual Impairment
1
1
Vomiting
1
1
Cyanosis
1
1
Cyst(s)
1
1
Arrhythmia
1
1
Atrial Fibrillation
1
1
Autoimmune Disorder
1
1
Burn(s)
1
1
Embolism
1
1
Embolus
1
1
High Blood Pressure/ Hypertension
1
1
Failure of Implant
1
1
Headache
1
1
Fatigue
1
1
Peripheral Edema
1
1
Valvular Insufficiency/ Regurgitation
1
1
Unspecified Respiratory Problem
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Covidien LLC
II
May-12-2015
2
Medtronic Inc.
III
May-12-2021
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