TPLC - Total Product Life Cycle

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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	4
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
RAPID-MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	1
SCIENTIA VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	3
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	208	209
Peeled/Delaminated	126	129
Break	113	113
Adverse Event Without Identified Device or Use Problem	22	22
Failure to Advance	21	21
Detachment of Device or Device Component	9	9
Insufficient Information	8	8
Material Fragmentation	8	8
Material Split, Cut or Torn	6	6
No Apparent Adverse Event	6	6
Incomplete or Missing Packaging	3	3
Material Separation	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
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
Packaging Problem	1	1
Migration	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	455	460
Foreign Body In Patient	40	40
Perforation of Vessels	10	10
Intracranial Hemorrhage	7	7
Insufficient Information	7	7
Hypersensitivity/Allergic reaction	5	5
Hemorrhage/Bleeding	5	5
Obstruction/Occlusion	4	4
Paralysis	4	4
Dysphasia	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
Speech Disorder	2	2
Muscle Weakness	2	2
Vasoconstriction	2	2
Fever	2	2
Foreign Body Embolism	2	2
Device Embedded In Tissue or Plaque	2	2
Stroke/CVA	1	1
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
Headache	1	1
Ischemia Stroke	1	1

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