TPLC - Total Product Life Cycle

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Device	catheter, intravascular occluding, temporary
Regulation Description	Vascular clamp.
Product Code	MJN
Regulation Number	870.4450
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABIOMED, INC.
	SE - WITH LIMITATIONS	1
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
FRONT LINE MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
NEURESCUE APS
	SUBSTANTIALLY EQUIVALENT	1
PHILIPS IMAGE GUIDED THERAPY DEVICES
	SUBSTANTIALLY EQUIVALENT	1
PRYTIME MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
RENALPRO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RENOVORX, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIEN MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	200	202
Inflation Problem	111	111
Adverse Event Without Identified Device or Use Problem	94	95
Leak/Splash	88	88
Fluid/Blood Leak	73	73
Deflation Problem	56	56
Burst Container or Vessel	53	53
Failure to Deflate	42	42
Material Puncture/Hole	40	40
Patient Device Interaction Problem	38	40
Break	33	35
Entrapment of Device	29	29
Difficult to Remove	19	19
Material Deformation	14	14
Fracture	11	11
Difficult to Open or Close	9	9
Thickening of Material	8	8
Physical Resistance/Sticking	7	7
Difficult to Advance	6	6
Failure to Advance	6	6
Improper or Incorrect Procedure or Method	5	5
Unintended Deflation	5	5
Detachment of Device or Device Component	5	5
Contamination	5	6
Positioning Failure	5	5
Obstruction of Flow	5	5
Gas/Air Leak	5	5
Material Split, Cut or Torn	4	4
Mechanical Problem	4	4
Unintended Movement	4	4
Defective Component	4	4
Packaging Problem	4	4
Device Dislodged or Dislocated	3	3
Positioning Problem	3	3
Failure to Unfold or Unwrap	3	3
Difficult to Insert	3	3
Flaked	2	2
No Apparent Adverse Event	2	2
Material Twisted/Bent	2	2
Use of Device Problem	2	2
Degraded	2	2
Air/Gas in Device	2	2
Material Integrity Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Failure to Eject	2	2
Device Slipped	2	2
Component Missing	1	1
Stretched	1	1
Insufficient Flow or Under Infusion	1	1
Material Perforation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	691	695
Vascular Dissection	47	49
Perforation of Vessels	29	30
Intracranial Hemorrhage	25	26
Thrombosis/Thrombus	22	22
Hemorrhage/Bleeding	21	21
Insufficient Information	20	20
Rupture	20	22
Obstruction/Occlusion	16	16
Ruptured Aneurysm	11	13
Ischemia	11	11
Embolism/Embolus	10	10
Unspecified Nervous System Problem	10	10
Ischemia Stroke	9	9
Thromboembolism	9	9
Foreign Body In Patient	7	7
Paresis	6	6
Nervous System Injury	5	5
Stroke/CVA	5	5
Aneurysm	5	5
Hematoma	5	5
Hydrocephalus	4	4
Vasoconstriction	4	4
Hemorrhagic Stroke	4	4
Cognitive Changes	4	5
Fistula	3	3
Foreign Body Embolism	3	3
Dysphasia	3	3
Muscle Weakness	3	3
Foreign Body Reaction	2	2
Unintended Radiation Exposure	2	2
Transient Ischemic Attack	2	2
Pulmonary Embolism	2	2
Cerebral Edema	2	2
Status Epilepticus	2	2
Paralysis	2	2
Air Embolism	2	2
Necrosis	2	2
Septic Shock	2	2
Neurogenic Shock	2	2
Nerve Damage	2	2
Cancer	2	2
Laceration(s)	2	2
Renal Impairment	2	2
Loss of Vision	2	2
Headache	2	2
Swelling/ Edema	2	2
Extravasation	2	2
Unspecified Tissue Injury	2	2
Stenosis	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	W. L. Gore & Associates Inc.	II	Aug-25-2021