TPLC - Total Product Life Cycle

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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

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
Deformation Due to Compressive Stress	3	3
Improper or Incorrect Procedure or Method	3	3
Migration	3	3
Device Contamination with Chemical or Other Material	3	3
Device Operates Differently Than Expected	2	2
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
Difficult to Advance	2	2
Material Puncture/Hole	2	2
Complete Blockage	2	2
Physical Resistance/Sticking	2	2
Off-Label Use	2	2
Stretched	1	1
Misfire	1	1
Failure to Deliver	1	1
Contamination	1	1
Occlusion Within Device	1	1
Material Integrity Problem	1	1
Device Damaged by Another Device	1	1
Infusion or Flow Problem	1	1
Defective Component	1	1
Insufficient Information	1	1
Device Handling Problem	1	1
Material Protrusion/Extrusion	1	1
No Apparent Adverse Event	1	1
Torn Material	1	1
Fracture	1	1
Device Dislodged or Dislocated	1	1
Protective Measures Problem	1	1
Appropriate Term/Code Not Available	1	1
Mechanical Problem	1	1
Break	1	1
Therapy Delivered to Incorrect Body Area	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
Granuloma	45	45
Foreign Body Reaction	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
Stroke/CVA	8	8
Discomfort	8	8
Bruise/Contusion	8	8
Unspecified Tissue Injury	7	7
Numbness	7	7
Death	7	7
Sepsis	7	7
Edema	7	7
Irritation	6	6
Thromboembolism	5	5
Bacterial Infection	5	5
Burning Sensation	5	5
Foreign Body In Patient	5	5