TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Reviews
Manufacturer	Decision
ARBOR ENDOVASCULAR, LLC
	SUBSTANTIALLY EQUIVALENT	5
ARTIRIA MEDICAL SA
	SUBSTANTIALLY EQUIVALENT	1
ASAHI INTECC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
ENLIGHT MEDICAL TECHNOLOGIES (SHENZHEN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
IMPERATIVE CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
PIRAEUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RAPID MEDICAL LTD.
	SUBSTANTIALLY EQUIVALENT	1
RAPID-MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SCIENTIA VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	5
SCIENTIA VASCULAR, LLC
	SUBSTANTIALLY EQUIVALENT	1
SHANGHAI ACHIEVA MEDICAL SUZHOU CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUZHOU ZENITH VASCULAR SCITECH LIMITED
	SUBSTANTIALLY EQUIVALENT	1
TERUMO MEDICAL PRODUCTS (HANGZHOU) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	238	239
Peeled/Delaminated	132	135
Break	123	123
Adverse Event Without Identified Device or Use Problem	26	26
Failure to Advance	26	26
Insufficient Device Problem Information	9	9
Detachment of Device or Device Component	9	9
Material Fragmentation	8	8
Material Split, Cut or Torn	6	6
No Apparent Adverse Event	6	6
Material Separation	5	5
Incomplete or Missing Packaging	3	3
Inaccurate Information	3	3
Mechanical Jam	3	3
Entrapment of Device	2	2
Migration or Expulsion of Device	1	1
Malposition of Device	1	1
Device Damaged Prior to Use	1	1
Material Puncture/Hole	1	1
Unclear Information	1	1
Unsealed Device Packaging	1	1
Material Integrity Problem	1	1
Contamination	1	2
Difficult to Insert	1	1
Stretched	1	1
Material Deformation	1	1
Packaging Problem	1	1
Appropriate Device Problem Term/Code Not Available	1	1
Migration	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	505	510
Foreign Body In Patient	45	45
Perforation of Vessels	13	13
Intracranial Hemorrhage	8	8
Insufficient Information	8	8
Hypersensitivity/Allergic reaction	5	5
Hemorrhage/Blood Loss/Bleeding	5	5
Obstruction/Occlusion	4	4
Paralysis	4	4
Headache	3	3
Muscle Weakness/Atrophy	2	2
Dysphasia	2	2
Stroke/CVA	2	2
Speech Disorder	2	2
Vasoconstriction	2	2
Fever	2	2
Foreign Body Embolism	2	2
Device Embedded In Tissue or Plaque	2	2
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available	2	2
Vascular Dissection	1	1
Inflammation	1	1
Ischemia	1	1
Visual Disturbances	1	1
Thrombosis/Thrombus	1	1
Visual Impairment	1	1
Aneurysm	1	1
Blurred Vision	1	1
Neuralgia	1	1
Ischemia Stroke	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Stryker Neurovascular	II	May-31-2024