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	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
1. K202182 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM ...
2. K210996 ZOOM (71, 55, 45, 35) Reperfusion Catheters; ZOOM ...
3. K211476 ZOOM 71 Reperfusion Catheter; ZOOM Aspiration Tubi ...
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	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	1553	1553
Break	564	564
Physical Resistance/Sticking	502	502
Fracture	295	295
Material Deformation	251	251
Stretched	164	164
Difficult to Remove	126	126
Failure to Advance	103	103
Material Separation	81	81
Retraction Problem	72	72
Material Twisted/Bent	60	60
Difficult to Advance	42	42
Crack	40	40
Suction Problem	40	40
Unraveled Material	35	35
Suction Failure	33	33
Fluid/Blood Leak	31	31
No Apparent Adverse Event	30	30
Detachment of Device or Device Component	29	29
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
Use of Device Problem	8	8
Activation Failure	7	7
Premature Separation	7	7
Appropriate Term/Code Not Available	6	6
Device Fell	5	5
Material Frayed	5	5
Misconnection	5	5
Power Problem	5	5
Deformation Due to Compressive Stress	4	4
Device Handling Problem	4	4
Insufficient Information	4	4
Device Contamination with Body Fluid	4	4
Activation Problem	4	4
Activation, Positioning or Separation Problem	4	4
Component or Accessory Incompatibility	3	3
Decrease in Suction	3	3
Migration	3	3
Device Dislodged or Dislocated	3	3
Unintended Movement	3	3
Connection Problem	3	3
Component Missing	3	3
Lack of Effect	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1249	1249
Intracranial Hemorrhage	652	652
No Consequences Or Impact To Patient	360	360
Thromboembolism	170	170
Hemorrhage/Bleeding	164	164
Vascular Dissection	156	156
Perforation of Vessels	146	146
Stroke/CVA	140	140
Ischemia Stroke	137	137
Vasoconstriction	134	134
Foreign Body In Patient	130	130
Insufficient Information	110	110
Embolism/Embolus	103	103
Obstruction/Occlusion	98	98
Unspecified Nervous System Problem	95	95
Hematoma	87	87
Swelling/ Edema	67	67
Thrombosis/Thrombus	66	66
Device Embedded In Tissue or Plaque	59	59
Death	56	56
Hemorrhagic Stroke	35	35
Extravasation	32	32
Cerebral Edema	32	32
Hemorrhage, Subarachnoid	30	30
Ischemia	29	29
Stenosis	29	29
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
Respiratory Failure	12	12
Embolus	12	12
Coma	12	12
No Code Available	11	11
Headache	11	11
Paresis	11	11
Heart Failure/Congestive Heart Failure	10	10
Nervous System Injury	10	10
Occlusion	10	10
Hydrocephalus	10	10
Convulsion/Seizure	9	9
Unspecified Infection	8	8
Aspiration/Inhalation	8	8