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
AKURA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ARGON MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	3
AVANTEC VASCULAR CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	2
CONTEGO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
DEVORO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	5
ENDOVASCULAR ENGINEERING
	SUBSTANTIALLY EQUIVALENT	1
ENDOVASCULAR ENGINEERING, INC.
	SUBSTANTIALLY EQUIVALENT	1
EXPANSE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K234073 ICE Aspiration System
ICHOR
	SUBSTANTIALLY EQUIVALENT	2
IMPERATIVE CARE, INC.
	SUBSTANTIALLY EQUIVALENT	2
INARI MEDICAL
	SUBSTANTIALLY EQUIVALENT	12
INARI MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	18
INNOVA VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
INQUIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	5
INTERVENE
	SUBSTANTIALLY EQUIVALENT	1
IRANI MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, IRELAND
	SUBSTANTIALLY EQUIVALENT	1
PENUMBRA, INC.
	SUBSTANTIALLY EQUIVALENT	14
	SE - WITH LIMITATIONS	1
SURMODICS,INC.
	SUBSTANTIALLY EQUIVALENT	5
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
Adverse Event Without Identified Device or Use Problem	217	217
Break	202	202
Physical Resistance/Sticking	163	163
Material Deformation	145	145
Fracture	130	130
Entrapment of Device	69	69
Obstruction of Flow	66	66
Electrical /Electronic Property Problem	47	47
Detachment of Device or Device Component	46	46
Use of Device Problem	43	43
Leak/Splash	39	39
Difficult to Remove	39	39
Improper or Incorrect Procedure or Method	36	36
Failure to Advance	35	35
Material Separation	32	32
Connection Problem	30	30
Suction Problem	25	25
Display or Visual Feedback Problem	20	20
Difficult to Advance	19	19
Suction Failure	17	17
Retraction Problem	14	14
Insufficient Information	12	12
Stretched	12	12
Circuit Failure	10	10
Fluid/Blood Leak	10	10
Patient-Device Incompatibility	7	7
Device Fell	7	7
Misconnection	6	6
Defective Device	6	6
Device Difficult to Setup or Prepare	6	6
Deformation Due to Compressive Stress	5	5
Migration	5	5
Pumping Problem	5	5
Material Twisted/Bent	5	5
Patient Device Interaction Problem	5	5
Material Fragmentation	5	5
Unraveled Material	5	5
Free or Unrestricted Flow	4	4
Activation, Positioning or Separation Problem	4	4
Mechanical Problem	4	4
Off-Label Use	4	4
Difficult to Insert	3	3
Failure to Power Up	3	3
Noise, Audible	3	3
Air/Gas in Device	3	3
Material Integrity Problem	3	3
Failure to Sense	3	3
Material Puncture/Hole	3	3
Material Split, Cut or Torn	3	3
Crack	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	743	743
No Consequences Or Impact To Patient	206	206
Pulmonary Embolism	60	60
Cardiac Arrest	55	55
Perforation of Vessels	43	43
Vascular Dissection	42	42
Foreign Body In Patient	40	40
Low Blood Pressure/ Hypotension	36	36
Hemoptysis	34	34
Great Vessel Perforation	25	25
Device Embedded In Tissue or Plaque	20	20
Low Oxygen Saturation	18	18
Hemorrhage/Bleeding	18	18
Respiratory Arrest	18	18
Anemia	18	18
Cardiac Perforation	18	18
Insufficient Information	15	15
Loss of consciousness	13	13
Thromboembolism	12	12
Hypoxia	12	12
Cardiogenic Shock	12	12
Pericardial Effusion	12	12
Tachycardia	11	11
Bradycardia	11	11
Intraoperative Pain	10	10
Cardiovascular Insufficiency	10	10
Thrombosis/Thrombus	10	10
Cardiac Tamponade	9	9
High Blood Pressure/ Hypertension	8	8
Embolism/Embolus	8	8
Hypovolemia	7	7
Cardiopulmonary Arrest	7	7
Unspecified Vascular Problem	6	6
Death	6	6
Hematoma	6	6
Extravasation	5	5
Discomfort	5	5
Pain	4	4
Chest Pain	4	4
Intracranial Hemorrhage	4	4
Obstruction/Occlusion	4	4
Vessel Or Plaque, Device Embedded In	4	4
Abdominal Pain	4	4
Stroke/CVA	4	4
Hypovolemic Shock	3	3
Abdominal Distention	3	3
Dyspnea	3	3
Perforation	3	3
Ischemia	3	3
Renal Failure	3	3