TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, thrombus retriever
Regulation Description	Percutaneous catheter.
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	6
BALT USA, LLC
	SUBSTANTIALLY EQUIVALENT	2
CERENOVUS INC.
	SUBSTANTIALLY EQUIVALENT	2
CERENOVUS, INC.
	SUBSTANTIALLY EQUIVALENT	2
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	1
IMPERATIVE CARE INC.
	SUBSTANTIALLY EQUIVALENT	3
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 LIMITED
	SUBSTANTIALLY EQUIVALENT	1
NEURAVI LTD.
	SUBSTANTIALLY EQUIVALENT	2
NEURAVI, LTD.
	SUBSTANTIALLY EQUIVALENT	1
PENUMBRA, INC.
	SUBSTANTIALLY EQUIVALENT	7
PERFUZE LTD
	SUBSTANTIALLY EQUIVALENT	1
PERFUZE LTD.
	SUBSTANTIALLY EQUIVALENT	3
Q'APEL MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RAPID MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	4
ROUTE 92 MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	3
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	1638	1638
Physical Resistance/Sticking	688	688
Break	632	634
Fracture	358	358
Material Deformation	310	310
Stretched	167	167
Difficult to Remove	130	130
Failure to Advance	116	116
Material Separation	102	102
Retraction Problem	82	82
Material Twisted/Bent	76	76
Difficult to Advance	48	48
Crack	43	43
Suction Problem	40	40
Detachment of Device or Device Component	36	36
Unraveled Material	36	37
Fluid/Blood Leak	35	35
Suction Failure	33	33
No Apparent Adverse Event	32	32
Material Puncture/Hole	24	24
Separation Failure	21	21
Leak/Splash	18	18
Deformation Due to Compressive Stress	14	14
Entrapment of Device	14	14
Patient-Device Incompatibility	13	13
Use of Device Problem	13	13
Packaging Problem	13	13
Activation Failure	12	12
Peeled/Delaminated	11	11
Material Split, Cut or Torn	10	10
Unclear Information	8	8
Premature Separation	7	7
Appropriate Term/Code Not Available	6	6
Material Frayed	5	5
Insufficient Information	5	5
Device Fell	5	5
Power Problem	5	5
Misconnection	5	5
Migration	5	5
Unintended Movement	4	4
Component or Accessory Incompatibility	4	4
Activation, Positioning or Separation Problem	4	4
Material Fragmentation	4	4
Activation Problem	4	4
Device Contamination with Body Fluid	4	4
Lack of Effect	4	4
Device Handling Problem	4	4
Material Integrity Problem	3	3
Contamination /Decontamination Problem	3	3
Connection Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1533	1534
Intracranial Hemorrhage	688	688
No Consequences Or Impact To Patient	360	360
Thromboembolism	180	180
Hemorrhage/Bleeding	175	175
Vascular Dissection	170	170
Perforation of Vessels	158	158
Foreign Body In Patient	156	156
Ischemia Stroke	155	155
Stroke/CVA	142	142
Vasoconstriction	135	135
Obstruction/Occlusion	120	120
Insufficient Information	115	115
Embolism/Embolus	108	108
Unspecified Nervous System Problem	98	98
Hematoma	90	90
Thrombosis/Thrombus	76	76
Swelling/ Edema	69	69
Device Embedded In Tissue or Plaque	60	60
Death	56	56
Hemorrhagic Stroke	40	40
Cerebral Edema	35	35
Extravasation	34	34
Stenosis	32	32
Hemorrhage, Subarachnoid	30	30
Ischemia	30	30
No Known Impact Or Consequence To Patient	29	30
Rupture	29	29
Pseudoaneurysm	26	26
Muscle Weakness	25	25
Fistula	25	25
Perforation	24	24
Infarction, Cerebral	22	22
Paralysis	21	21
Dysphasia	19	19
Hemorrhage, Cerebral	16	16
Cognitive Changes	14	14
Paresis	13	13
Nervous System Injury	13	13
Headache	13	13
Speech Disorder	13	13
Respiratory Failure	12	12
Coma	12	12
Embolus	12	12
No Code Available	11	11
Occlusion	10	10
Hydrocephalus	10	10
Heart Failure/Congestive Heart Failure	10	10
Convulsion/Seizure	9	9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	9	9