TPLC - Total Product Life Cycle

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Device	peripheral mechanical thrombectomy with aspiration
Definition	To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.
Product Code	QEW
Regulation Number	870.5150
Device Class	2

Premarket Reviews
Manufacturer	Decision
2MG, INC
	SUBSTANTIALLY EQUIVALENT	1
880 MEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
ARGON MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	3
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	2
CONTEGO MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
CONTEGO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
DEVORO MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
DEVORO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
ENDOVASCULAR ENGINEERING
	SUBSTANTIALLY EQUIVALENT	1
EXPANSE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
ICHOR
	SUBSTANTIALLY EQUIVALENT	2
INARI MEDICAL
	SUBSTANTIALLY EQUIVALENT	15
INARI MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
INARI MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	13
INNOVA VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
INQUIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
IRANI MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PENUMBRA, INC
	SUBSTANTIALLY EQUIVALENT	1
PENUMBRA, INC.
	SUBSTANTIALLY EQUIVALENT	12
	SE - WITH LIMITATIONS	1
SURMODICS INC.
	SUBSTANTIALLY EQUIVALENT	2
SURMODICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
TRUVIC MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
VASCULAR MEDCURE, INC.
	SUBSTANTIALLY EQUIVALENT	5
VESALIO
	SUBSTANTIALLY EQUIVALENT	1
VETEX MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	192	192
Material Deformation	156	156
Physical Resistance/Sticking	154	154
Adverse Event Without Identified Device or Use Problem	145	145
Obstruction of Flow	65	65
Fracture	58	58
Electrical /Electronic Property Problem	47	47
Entrapment of Device	43	43
Failure to Advance	39	39
Leak/Splash	32	32
Improper or Incorrect Procedure or Method	30	30
Connection Problem	30	30
Detachment of Device or Device Component	27	27
Use of Device Problem	23	23
Difficult to Remove	21	21
Suction Problem	20	20
Display or Visual Feedback Problem	18	18
Suction Failure	17	17
Difficult to Advance	16	16
Material Separation	13	13
Stretched	11	11
Circuit Failure	10	10
Fluid/Blood Leak	9	9
Insufficient Information	8	8
Retraction Problem	8	8
Patient-Device Incompatibility	7	7
Device Fell	7	7
Misconnection	6	6
Unraveled Material	6	6
Deformation Due to Compressive Stress	5	5
Defective Device	5	5
Patient Device Interaction Problem	5	5
Material Twisted/Bent	5	5
Activation, Positioning or Separation Problem	4	4
Mechanical Problem	4	4
Free or Unrestricted Flow	4	4
Device Difficult to Setup or Prepare	4	4
Noise, Audible	3	3
Failure to Power Up	3	3
Difficult to Insert	3	3
Material Fragmentation	3	3
Material Integrity Problem	3	3
Off-Label Use	3	3
Failure to Sense	3	3
Material Puncture/Hole	3	3
Pumping Problem	3	3
Material Frayed	2	2
Decrease in Suction	2	2
Device Damaged by Another Device	2	2
Infusion or Flow Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	604	604
No Consequences Or Impact To Patient	238	238
Cardiac Arrest	48	48
Pulmonary Embolism	38	38
Perforation of Vessels	33	33
Hemoptysis	32	32
Low Blood Pressure/ Hypotension	29	29
Foreign Body In Patient	23	23
Vascular Dissection	21	21
Device Embedded In Tissue or Plaque	20	20
Respiratory Arrest	18	18
Low Oxygen Saturation	18	18
Cardiac Perforation	17	17
Great Vessel Perforation	15	15
Loss of consciousness	13	13
Insufficient Information	12	12
Pericardial Effusion	12	12
Tachycardia	11	11
Hemorrhage/Bleeding	11	11
Anemia	11	11
Hypoxia	10	10
Intraoperative Pain	10	10
Cardiovascular Insufficiency	9	9
Cardiogenic Shock	9	9
Thromboembolism	9	9
High Blood Pressure/ Hypertension	8	8
Bradycardia	8	8
Cardiac Tamponade	8	8
Cardiopulmonary Arrest	7	7
Hypovolemia	7	7
Embolism/Embolus	7	7
Death	6	6
Unspecified Vascular Problem	6	6
Hematoma	5	5
Discomfort	5	5
Pain	4	4
Chest Pain	4	4
Thrombosis/Thrombus	4	4
Intracranial Hemorrhage	4	4
Stroke/CVA	4	4
Abdominal Pain	4	4
Vessel Or Plaque, Device Embedded In	4	4
Abdominal Distention	3	3
Ischemia	3	3
Dyspnea	3	3
Hypovolemic Shock	3	3
Renal Failure	3	3
Cough	3	3
Oversedation	2	2
Ventricular Fibrillation	2	2