TPLC - Total Product Life Cycle

show TPLC since

Device	guide, wire, catheter, neurovasculature
Product Code	MOF
Regulation Number	870.1330
Device Class	2

Premarket Reviews
Manufacturer	Decision
ARTIRIA MEDICAL SA
	SUBSTANTIALLY EQUIVALENT	1
ASAHI INTECC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	8
BALT USA, LLC
	SUBSTANTIALLY EQUIVALENT	1
CODMAN & SHURTLEFF, INC.
	SUBSTANTIALLY EQUIVALENT	1
MICRO VENTION INC.
	SUBSTANTIALLY EQUIVALENT	1
MICROVENTION INC.
	SUBSTANTIALLY EQUIVALENT	1
MICROVENTION, INC.
	SUBSTANTIALLY EQUIVALENT	4
MIVI NEUROSCIENCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
RAPID-MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
SCIENTIA VASCULAR INC
	SUBSTANTIALLY EQUIVALENT	1
SCIENTIA VASCULAR LLC
	SUBSTANTIALLY EQUIVALENT	2
SCIENTIA VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
SCIENTIA VASCULAR, LLC
	SUBSTANTIALLY EQUIVALENT	1
STRYKER
	SUBSTANTIALLY EQUIVALENT	1
STRYKER NEUROVASCULAR
	SUBSTANTIALLY EQUIVALENT	1
TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Peeled/Delaminated	105	105
Fracture	95	95
Break	31	31
Adverse Event Without Identified Device or Use Problem	27	27
Detachment of Device or Device Component	20	20
Insufficient Information	13	13
Material Fragmentation	8	8
Detachment Of Device Component	4	4
Material Split, Cut or Torn	4	4
Inaccurate Information	3	3
Delamination	3	3
Material Separation	3	3
Stretched	2	2
Solder Joint Fracture	2	2
Malposition of Device	1	1
Material Deformation	1	1
Material Integrity Problem	1	1
Unraveled Material	1	1
Device Damaged Prior to Use	1	1
Component Falling	1	1
Contamination	1	1
Migration or Expulsion of Device	1	1
Unsealed Device Packaging	1	1
Unclear Information	1	1
Physical Resistance/Sticking	1	1
Appropriate Term/Code Not Available	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	210	210
No Consequences Or Impact To Patient	29	29
Foreign Body In Patient	21	21
Perforation of Vessels	14	14
Intracranial Hemorrhage	13	13
Hemorrhage/Bleeding	5	5
Insufficient Information	5	5
No Known Impact Or Consequence To Patient	4	4
Device Embedded In Tissue or Plaque	4	4
Patient Problem/Medical Problem	3	3
Hypersensitivity/Allergic reaction	3	3
No Patient Involvement	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Muscle Weakness	2	2
Paralysis	2	2
Hemorrhage, Cerebral	2	2
Death	2	2
Embolism	1	1
Granuloma	1	1
Headache	1	1
Autoimmune Reaction	1	1
Stroke/CVA	1	1
Paresis	1	1
Increased Sensitivity	1	1
Vasoconstriction	1	1
Nausea	1	1
Inflammation	1	1
Vascular Dissection	1	1
No Information	1	1
No Code Available	1	1
Missing Value Reason	1	1
Foreign Body Embolism	1	1
Blurred Vision	1	1
Visual Impairment	1	1
Weakness	1	1
Tingling	1	1
Dysphasia	1	1
Numbness	1	1
Coma	1	1
Obstruction/Occlusion	1	1