TPLC - Total Product Life Cycle

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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	4
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
IMPERATIVE CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
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	7
PERFUZE LTD.
	SUBSTANTIALLY EQUIVALENT	3
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	1566	1566
Break	576	576
Physical Resistance/Sticking	542	542
Fracture	315	315
Material Deformation	260	260
Stretched	165	165
Difficult to Remove	127	127
Failure to Advance	106	106
Material Separation	85	85
Retraction Problem	77	77
Material Twisted/Bent	62	62
Difficult to Advance	42	42
Crack	41	41
Suction Problem	40	40
Unraveled Material	35	35
Suction Failure	33	33
Fluid/Blood Leak	32	32
No Apparent Adverse Event	30	30
Detachment of Device or Device Component	29	29
Material Puncture/Hole	24	24
Separation Failure	19	19
Leak/Splash	18	18
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
Use of Device Problem	9	9
Activation Failure	8	8
Unclear Information	8	8
Premature Separation	7	7
Appropriate Term/Code Not Available	6	6
Power Problem	5	5
Misconnection	5	5
Material Frayed	5	5
Device Fell	5	5
Insufficient Information	5	5
Deformation Due to Compressive Stress	4	4
Activation, Positioning or Separation Problem	4	4
Device Handling Problem	4	4
Activation Problem	4	4
Migration	4	4
Device Contamination with Body Fluid	4	4
Component or Accessory Incompatibility	3	3
Component Missing	3	3
Decrease in Suction	3	3
Lack of Effect	3	3
Unintended Movement	3	3
Connection Problem	3	3
Device Dislodged or Dislocated	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1312	1312
Intracranial Hemorrhage	658	658
No Consequences Or Impact To Patient	360	360
Thromboembolism	172	172
Hemorrhage/Bleeding	167	167
Vascular Dissection	157	157
Perforation of Vessels	148	148
Ischemia Stroke	141	141
Stroke/CVA	140	140
Foreign Body In Patient	135	135
Vasoconstriction	134	134
Insufficient Information	110	110
Embolism/Embolus	103	103
Obstruction/Occlusion	98	98
Unspecified Nervous System Problem	95	95
Hematoma	89	89
Thrombosis/Thrombus	70	70
Swelling/ Edema	67	67
Device Embedded In Tissue or Plaque	59	59
Death	56	56
Hemorrhagic Stroke	37	37
Extravasation	33	33
Cerebral Edema	32	32
Hemorrhage, Subarachnoid	30	30
Stenosis	30	30
Ischemia	30	30
No Known Impact Or Consequence To Patient	29	29
Rupture	28	28
Pseudoaneurysm	25	25
Fistula	24	24
Perforation	24	24
Infarction, Cerebral	22	22
Muscle Weakness	21	21
Paralysis	17	17
Dysphasia	17	17
Hemorrhage, Cerebral	16	16
Cognitive Changes	14	14
Embolus	12	12
Respiratory Failure	12	12
Paresis	12	12
Coma	12	12
Headache	11	11
Nervous System Injury	11	11
No Code Available	11	11
Hydrocephalus	10	10
Heart Failure/Congestive Heart Failure	10	10
Occlusion	10	10
Convulsion/Seizure	9	9
Aspiration/Inhalation	8	8
Unspecified Infection	8	8