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	4
AVANTEC VASCULAR CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	2
CONTEGO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
DEVORO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
ENDOVASCULAR ENGINEERING
	SUBSTANTIALLY EQUIVALENT	1
ENDOVASCULAR ENGINEERING, INC.
	SUBSTANTIALLY EQUIVALENT	1
EXPANSE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
ICHOR
	SUBSTANTIALLY EQUIVALENT	2
IMPERATIVE CARE, INC.
	SUBSTANTIALLY EQUIVALENT	2
INARI MEDICAL
	SUBSTANTIALLY EQUIVALENT	9
INARI MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	17
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	11
	SE - WITH LIMITATIONS	1
SURMODICS,INC.
	SUBSTANTIALLY EQUIVALENT	4
TRUVIC MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
VERGE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
VESALIO
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	234	234
Break	186	186
Fracture	143	143
Physical Resistance/Sticking	142	142
Material Deformation	120	120
Entrapment of Device	80	80
Detachment of Device or Device Component	52	52
Material Separation	43	43
Use of Device Problem	42	42
Difficult to Remove	40	40
Leak/Splash	37	37
Improper or Incorrect Procedure or Method	31	31
Electrical /Electronic Property Problem	29	29
Connection Problem	24	24
Failure to Advance	24	24
Display or Visual Feedback Problem	20	20
Suction Problem	18	18
Difficult to Advance	17	17
Retraction Problem	15	15
Suction Failure	11	11
Stretched	9	9
Fluid/Blood Leak	8	8
Insufficient Information	8	8
Deformation Due to Compressive Stress	7	7
Defective Device	6	6
Device Difficult to Setup or Prepare	6	6
Pumping Problem	5	5
Migration	5	5
Material Twisted/Bent	5	5
Material Fragmentation	5	5
Obstruction of Flow	5	5
Activation, Positioning or Separation Problem	4	4
Mechanical Problem	4	4
Off-Label Use	4	4
Patient-Device Incompatibility	4	4
Device Fell	4	4
Material Integrity Problem	4	4
Mechanical Jam	3	3
Failure to Power Up	3	3
Unraveled Material	3	3
Difficult to Insert	3	3
Air/Gas in Device	3	3
Material Split, Cut or Torn	3	3
Material Puncture/Hole	3	3
Material Frayed	2	2
Device Damaged by Another Device	2	2
Infusion or Flow Problem	2	2
Misconnection	2	2
Vibration	2	2
Free or Unrestricted Flow	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	660	660
Pulmonary Embolism	58	58
Cardiac Arrest	54	54
Vascular Dissection	47	47
Perforation of Vessels	45	45
Foreign Body In Patient	42	42
Low Blood Pressure/ Hypotension	34	34
Hemoptysis	33	33
No Consequences Or Impact To Patient	31	31
Great Vessel Perforation	24	24
Cardiac Perforation	20	20
Low Oxygen Saturation	19	19
Hemorrhage/Bleeding	19	19
Anemia	19	19
Device Embedded In Tissue or Plaque	16	16
Respiratory Arrest	16	16
Insufficient Information	16	16
Thromboembolism	14	14
Loss of consciousness	13	13
Tachycardia	12	12
Hypoxia	11	11
Bradycardia	11	11
Pericardial Effusion	11	11
Embolism/Embolus	10	10
Cardiogenic Shock	10	10
Cardiac Tamponade	10	10
Thrombosis/Thrombus	10	10
Intraoperative Pain	9	9
Cardiovascular Insufficiency	9	9
High Blood Pressure/ Hypertension	8	8
Hypovolemia	6	6
Stroke/CVA	6	6
Unspecified Vascular Problem	6	6
Hematoma	6	6
Extravasation	5	5
Pain	5	5
Discomfort	5	5
Foreign Body Embolism	4	4
Chest Pain	4	4
Abdominal Pain	4	4
Intracranial Hemorrhage	4	4
Obstruction/Occlusion	4	4
Ischemia	4	4
Cough	3	3
Renal Failure	3	3
Abdominal Distention	3	3
Dyspnea	3	3
Hypovolemic Shock	2	2
Pancreatitis	2	2
Respiratory Insufficiency	2	2