TPLC - Total Product Life Cycle

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Device	catheter, thrombus retriever
Definition	The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary, and neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode.
Product Code	NRY
Regulation Number	870.1250
Device Class	2

Premarket Reviews
Manufacturer	Decision
ALEMBIC, LLC
	SUBSTANTIALLY EQUIVALENT	3
BALT USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
CERENOVUS INC.
	SUBSTANTIALLY EQUIVALENT	1
CERENOVUS, INC.
	SUBSTANTIALLY EQUIVALENT	2
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMPERATIVE CARE INC.
	SUBSTANTIALLY EQUIVALENT	3
MICRO THERAPEUTICS INC. D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	1
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	1
MICROVENTION INC.
	SUBSTANTIALLY EQUIVALENT	1
NEURAVI LTD.
	SUBSTANTIALLY EQUIVALENT	2
NEURAVI, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PENUMBRA, INC.
	SUBSTANTIALLY EQUIVALENT	6
PERFUZE LTD.
	SUBSTANTIALLY EQUIVALENT	2
Q'APEL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RAPID MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	3
ROUTE 92 MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
SCIENTIA VASCULAR INC
	SUBSTANTIALLY EQUIVALENT	1
WALLABY MEDICAL
	SUBSTANTIALLY EQUIVALENT	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1530	1530
Break	557	557
Physical Resistance/Sticking	473	473
Fracture	289	289
Material Deformation	243	243
Stretched	164	164
Difficult to Remove	126	126
Failure to Advance	101	101
Material Separation	80	80
Retraction Problem	72	72
Material Twisted/Bent	59	59
Difficult to Advance	41	41
Suction Problem	40	40
Crack	35	35
Unraveled Material	35	35
Suction Failure	33	33
No Apparent Adverse Event	30	30
Fluid/Blood Leak	28	28
Detachment of Device or Device Component	27	27
Material Puncture/Hole	23	23
Leak/Splash	18	18
Separation Failure	16	16
Patient-Device Incompatibility	13	13
Entrapment of Device	12	12
Peeled/Delaminated	10	10
Packaging Problem	10	10
Material Split, Cut or Torn	9	9
Unclear Information	8	8
Premature Separation	7	7
Activation Failure	7	7
Appropriate Term/Code Not Available	6	6
Use of Device Problem	6	6
Power Problem	5	5
Misconnection	5	5
Material Frayed	5	5
Device Fell	5	5
Deformation Due to Compressive Stress	4	4
Insufficient Information	4	4
Activation, Positioning or Separation Problem	4	4
Device Handling Problem	4	4
Device Contamination with Body Fluid	4	4
Component or Accessory Incompatibility	3	3
Component Missing	3	3
Decrease in Suction	3	3
Connection Problem	3	3
Lack of Effect	3	3
Unintended Movement	3	3
Activation Problem	3	3
Device Dislodged or Dislocated	3	3
Migration	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1209	1209
Intracranial Hemorrhage	643	643
No Consequences Or Impact To Patient	360	360
Thromboembolism	170	170
Hemorrhage/Bleeding	159	159
Vascular Dissection	152	152
Perforation of Vessels	142	142
Stroke/CVA	139	139
Vasoconstriction	132	132
Ischemia Stroke	132	132
Foreign Body In Patient	129	129
Insufficient Information	106	106
Embolism/Embolus	101	101
Obstruction/Occlusion	95	95
Unspecified Nervous System Problem	93	93
Hematoma	84	84
Swelling/ Edema	66	66
Thrombosis/Thrombus	60	60
Device Embedded In Tissue or Plaque	59	59
Death	56	56
Hemorrhagic Stroke	34	34
Cerebral Edema	32	32
Extravasation	31	31
Hemorrhage, Subarachnoid	30	30
No Known Impact Or Consequence To Patient	29	29
Stenosis	29	29
Rupture	28	28
Ischemia	27	27
Pseudoaneurysm	25	25
Fistula	24	24
Perforation	23	23
Infarction, Cerebral	22	22
Muscle Weakness	20	20
Paralysis	17	17
Hemorrhage, Cerebral	16	16
Dysphasia	16	16
Cognitive Changes	14	14
Respiratory Failure	12	12
Embolus	12	12
Coma	12	12
No Code Available	11	11
Paresis	11	11
Headache	11	11
Occlusion	10	10
Heart Failure/Congestive Heart Failure	10	10
Hydrocephalus	10	10
Nervous System Injury	9	9
Convulsion/Seizure	9	9
Aspiration/Inhalation	8	8
Aneurysm	8	8