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TPLC
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show TPLC since
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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
2
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
60
60
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
578
578
Biocompatibility
395
395
Patient-Device Incompatibility
74
74
Migration or Expulsion of Device
17
17
Detachment of Device or Device Component
15
15
Defective Device
11
11
Activation, Positioning or Separation Problem
10
10
Obstruction of Flow
9
9
Use of Device Problem
7
7
Material Deformation
6
6
Difficult to Remove
6
6
Compatibility Problem
5
5
Migration
3
3
Device Contamination with Chemical or Other Material
3
3
Improper or Incorrect Procedure or Method
3
3
Deformation Due to Compressive Stress
3
3
Partial Blockage
2
2
Delivered as Unsterile Product
2
2
Device Difficult to Setup or Prepare
2
2
Difficult to Insert
2
2
Positioning Problem
2
2
Physical Resistance/Sticking
2
2
Off-Label Use
2
2
Device Operates Differently Than Expected
2
2
Difficult to Advance
2
2
Complete Blockage
2
2
Material Puncture/Hole
2
2
Material Integrity Problem
1
1
Defective Component
1
1
Misfire
1
1
Stretched
1
1
Break
1
1
Occlusion Within Device
1
1
Mechanical Problem
1
1
Therapy Delivered to Incorrect Body Area
1
1
Protective Measures Problem
1
1
Device Dislodged or Dislocated
1
1
Appropriate Term/Code Not Available
1
1
Failure to Deliver
1
1
Contamination
1
1
Fracture
1
1
Infusion or Flow Problem
1
1
Device Damaged by Another Device
1
1
Insufficient Information
1
1
Device Handling Problem
1
1
Torn Material
1
1
Material Protrusion/Extrusion
1
1
No Apparent Adverse Event
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Hypersensitivity/Allergic reaction
262
262
Pain
190
190
Patient Problem/Medical Problem
146
146
Thrombosis/Thrombus
133
133
Phlebitis
111
111
Unspecified Infection
110
110
Rash
93
93
Itching Sensation
93
93
Reaction
91
91
Swelling/ Edema
90
90
Local Reaction
79
79
Inflammation
74
74
Thrombus
67
67
Erythema
59
59
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
30
30
Ulcer
24
24
Skin Irritation
23
23
Fever
23
23
Cellulitis
22
22
Skin Inflammation/ Irritation
21
21
Injury
19
19
Abscess
18
18
Urticaria
18
18
Insufficient Information
17
17
Skin Inflammation
13
13
Dyspnea
12
12
Skin Discoloration
12
12
Ecchymosis
9
9
Purulent Discharge
9
9
Ulceration
8
8
Hematoma
8
8
Discomfort
8
8
Stroke/CVA
8
8
Bruise/Contusion
8
8
Sepsis
7
7
Unspecified Tissue Injury
7
7
Numbness
7
7
Edema
7
7
Death
7
7
Irritation
6
6
Bacterial Infection
5
5
Thromboembolism
5
5
Burning Sensation
5
5
Foreign Body In Patient
5
5
Recalls
Manufacturer
Recall Class
Date Posted
1
Covidien LLC
II
May-12-2015
2
Medtronic Inc.
III
May-12-2021
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