TPLC - Total Product Life Cycle

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Device	peripheral mechanical thrombectomy with aspiration
Regulation Description	Embolectomy catheter.
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
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	11
INARI MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	1
INARI MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	16
INNOVA VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
INQUIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	4
IRANI MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
PENUMBRA, INC
	SUBSTANTIALLY EQUIVALENT	1
PENUMBRA, INC.
	SUBSTANTIALLY EQUIVALENT	12
	SE - WITH LIMITATIONS	1
SURMODICS INC.
	SUBSTANTIALLY EQUIVALENT	3
SURMODICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
TRUVIC MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	2
VASCULAR MEDCURE, INC.
	SUBSTANTIALLY EQUIVALENT	3
VESALIO
	SUBSTANTIALLY EQUIVALENT	1
VETEX MEDICAL, LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Break	189	189
Adverse Event Without Identified Device or Use Problem	172	172
Physical Resistance/Sticking	150	150
Material Deformation	142	142
Fracture	80	80
Obstruction of Flow	66	66
Entrapment of Device	54	54
Electrical /Electronic Property Problem	47	47
Leak/Splash	35	35
Failure to Advance	35	35
Difficult to Remove	35	35
Improper or Incorrect Procedure or Method	33	33
Detachment of Device or Device Component	32	32
Connection Problem	30	30
Use of Device Problem	30	30
Suction Problem	23	23
Material Separation	20	20
Display or Visual Feedback Problem	19	19
Suction Failure	17	17
Difficult to Advance	17	17
Retraction Problem	12	12
Stretched	11	11
Circuit Failure	10	10
Fluid/Blood Leak	9	9
Insufficient Information	9	9
Patient-Device Incompatibility	7	7
Device Fell	7	7
Misconnection	6	6
Deformation Due to Compressive Stress	5	5
Material Twisted/Bent	5	5
Device Difficult to Setup or Prepare	5	5
Unraveled Material	5	5
Patient Device Interaction Problem	5	5
Defective Device	5	5
Pumping Problem	5	5
Activation, Positioning or Separation Problem	4	4
Free or Unrestricted Flow	4	4
Mechanical Problem	4	4
Off-Label Use	4	4
Noise, Audible	3	3
Material Fragmentation	3	3
Difficult to Insert	3	3
Air/Gas in Device	3	3
Failure to Power Up	3	3
Material Integrity Problem	3	3
Failure to Sense	3	3
Material Puncture/Hole	3	3
Material Frayed	2	2
No Flow	2	2
Decrease in Suction	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	657	657
No Consequences Or Impact To Patient	206	206
Cardiac Arrest	50	50
Pulmonary Embolism	49	49
Perforation of Vessels	39	39
Low Blood Pressure/ Hypotension	33	33
Hemoptysis	32	32
Foreign Body In Patient	30	30
Vascular Dissection	25	25
Device Embedded In Tissue or Plaque	20	20
Low Oxygen Saturation	18	18
Respiratory Arrest	18	18
Cardiac Perforation	18	18
Great Vessel Perforation	16	16
Anemia	16	16
Hemorrhage/Bleeding	15	15
Loss of consciousness	13	13
Hypoxia	12	12
Insufficient Information	12	12
Pericardial Effusion	12	12
Tachycardia	11	11
Cardiogenic Shock	11	11
Intraoperative Pain	10	10
Thromboembolism	10	10
Cardiovascular Insufficiency	10	10
Bradycardia	9	9
Cardiac Tamponade	9	9
High Blood Pressure/ Hypertension	8	8
Thrombosis/Thrombus	8	8
Hypovolemia	7	7
Cardiopulmonary Arrest	7	7
Embolism/Embolus	7	7
Unspecified Vascular Problem	6	6
Death	6	6
Hematoma	5	5
Discomfort	5	5
Extravasation	4	4
Pain	4	4
Chest Pain	4	4
Intracranial Hemorrhage	4	4
Vessel Or Plaque, Device Embedded In	4	4
Abdominal Pain	4	4
Stroke/CVA	4	4
Abdominal Distention	3	3
Hypovolemic Shock	3	3
Dyspnea	3	3
Ischemia	3	3
Renal Failure	3	3
Cough	3	3
Oversedation	2	2