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	2
ARTIRIA MEDICAL SA
	SUBSTANTIALLY EQUIVALENT	1
ASAHI INTECC CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
ENLIGHT MEDICAL TECHNOLOGIES (SHENZHEN) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
IMPERATIVE CARE, INC.
	SUBSTANTIALLY EQUIVALENT	1
MICROVENTION, INC.
	SUBSTANTIALLY EQUIVALENT	2
RAPID-MEDICAL , LTD.
	SUBSTANTIALLY EQUIVALENT	2
SCIENTIA VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	3
SCIENTIA VASCULAR, LLC
	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
Fracture	184	185
Peeled/Delaminated	125	128
Break	80	80
Adverse Event Without Identified Device or Use Problem	23	23
Detachment of Device or Device Component	14	14
Failure to Advance	9	9
Insufficient Information	8	8
Material Fragmentation	8	8
Material Split, Cut or Torn	6	6
No Apparent Adverse Event	6	6
Material Separation	4	4
Incomplete or Missing Packaging	3	3
Inaccurate Information	3	3
Mechanical Jam	3	3
Entrapment of Device	2	2
Stretched	2	2
Solder Joint Fracture	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
Material Deformation	1	1
Packaging Problem	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	386	391
Foreign Body In Patient	36	36
Perforation of Vessels	12	12
No Consequences Or Impact To Patient	8	8
Intracranial Hemorrhage	7	7
Insufficient Information	6	6
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
Device Embedded In Tissue or Plaque	2	2
Stroke/CVA	1	1
No Code Available	1	1
Vascular Dissection	1	1
Inflammation	1	1
Ischemia	1	1
Thrombosis/Thrombus	1	1
No Patient Involvement	1	1
Foreign Body Embolism	1	1
Paresis	1	1
Visual Impairment	1	1
Aneurysm	1	1
Blurred Vision	1	1
Headache	1	1

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