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	217	219
Inflation Problem	113	113
Adverse Event Without Identified Device or Use Problem	101	102
Leak/Splash	100	100
Fluid/Blood Leak	74	74
Deflation Problem	61	61
Burst Container or Vessel	56	56
Failure to Deflate	43	43
Patient Device Interaction Problem	43	45
Material Puncture/Hole	40	40
Break	35	37
Entrapment of Device	29	29
Difficult to Remove	20	20
Material Deformation	19	19
Fracture	11	11
Difficult to Open or Close	9	9
Detachment of Device or Device Component	8	8
Physical Resistance/Sticking	8	8
Difficult to Advance	8	8
Thickening of Material	8	8
Unintended Deflation	7	7
Gas/Air Leak	7	7
Improper or Incorrect Procedure or Method	6	6
Failure to Advance	6	6
Packaging Problem	5	5
Flaked	5	5
Obstruction of Flow	5	5
Positioning Failure	5	5
Contamination	5	6
Defective Component	4	4
Unintended Movement	4	4
Mechanical Problem	4	4
Material Split, Cut or Torn	4	4
Degraded	3	3
Difficult to Insert	3	3
Device Dislodged or Dislocated	3	3
Positioning Problem	3	3
Failure to Unfold or Unwrap	3	3
Air/Gas in Device	2	2
Use of Device Problem	2	2
Material Integrity Problem	2	2
Manufacturing, Packaging or Shipping Problem	2	2
Material Twisted/Bent	2	2
No Apparent Adverse Event	2	2
Failure to Eject	2	2
Device Slipped	2	2
Inaccurate Information	1	1
Material Too Soft/Flexible	1	1
Display or Visual Feedback Problem	1	1
Material Separation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	740	744
Vascular Dissection	51	53
Perforation of Vessels	35	36
Intracranial Hemorrhage	27	28
Thrombosis/Thrombus	24	24
Hemorrhage/Bleeding	21	21
Insufficient Information	20	20
Rupture	20	22
Obstruction/Occlusion	16	16
Embolism/Embolus	15	15
Ischemia	11	11
Ruptured Aneurysm	11	13
Unspecified Nervous System Problem	10	10
Ischemia Stroke	9	9
Thromboembolism	9	9
Foreign Body In Patient	8	8
Paresis	6	6
Stroke/CVA	5	5
Nervous System Injury	5	5
Aneurysm	5	5
Hematoma	5	5
Hemorrhagic Stroke	5	5
Hydrocephalus	4	4
Vasoconstriction	4	4
Cognitive Changes	4	5
Foreign Body Embolism	3	3
Convulsion/Seizure	3	3
Muscle Weakness	3	3
Brain Injury	3	3
Pulmonary Embolism	3	3
Fistula	3	3
Dysphasia	3	3
Headache	2	2
Pseudoaneurysm	2	2
Blurred Vision	2	2
Loss of Vision	2	2
Swelling/ Edema	2	2
Unspecified Tissue Injury	2	2
Stenosis	2	2
Cancer	2	2
Status Epilepticus	2	2
Extravasation	2	2
Renal Impairment	2	2
Cerebral Edema	2	2
Laceration(s)	2	2
Unintended Radiation Exposure	2	2
Neurogenic Shock	2	2
Septic Shock	2	2
Nerve Damage	2	2
Paralysis	2	2

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