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
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
EXPANSE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	210	210
Break	199	199
Physical Resistance/Sticking	161	161
Material Deformation	145	145
Fracture	126	126
Entrapment of Device	67	67
Obstruction of Flow	66	66
Electrical /Electronic Property Problem	47	47
Detachment of Device or Device Component	42	42
Use of Device Problem	42	42
Leak/Splash	39	39
Difficult to Remove	39	39
Improper or Incorrect Procedure or Method	36	36
Failure to Advance	35	35
Connection Problem	30	30
Material Separation	29	29
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	9	9
Patient-Device Incompatibility	7	7
Device Fell	7	7
Misconnection	6	6
Defective Device	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
Device Difficult to Setup or Prepare	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
Material Fragmentation	3	3
Failure to Power Up	3	3
Noise, Audible	3	3
Air/Gas in Device	3	3
Material Integrity Problem	3	3
Material Split, Cut or Torn	3	3
Failure to Sense	3	3
Material Puncture/Hole	3	3
Material Frayed	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	733	733
No Consequences Or Impact To Patient	206	206
Pulmonary Embolism	59	59
Cardiac Arrest	55	55
Perforation of Vessels	43	43
Foreign Body In Patient	39	39
Vascular Dissection	37	37
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
Respiratory Arrest	18	18
Anemia	18	18
Cardiac Perforation	18	18
Hemorrhage/Bleeding	16	16
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