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
ARCH CATHETER, LLC
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
FRONT LINE MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
NEURESCUE APS
	SUBSTANTIALLY EQUIVALENT	1
PRYTIME MEDICAL DEVICES, INC
	SUBSTANTIALLY EQUIVALENT	1
PRYTIME MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	1
RENALPRO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RENOVORX, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPECTRANETICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
ZIEN MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	188	188
Inflation Problem	103	103
Adverse Event Without Identified Device or Use Problem	98	98
Deflation Problem	78	78
Leak/Splash	78	78
Fluid/Blood Leak	76	76
Failure to Deflate	50	50
Burst Container or Vessel	47	47
Material Puncture/Hole	46	46
Break	37	37
Entrapment of Device	28	28
Patient Device Interaction Problem	27	27
Difficult to Remove	17	17
Material Deformation	13	13
Difficult to Open or Close	11	11
Fracture	10	10
Improper or Incorrect Procedure or Method	8	8
Physical Resistance/Sticking	8	8
Mechanical Problem	7	7
Gas/Air Leak	6	6
Difficult to Advance	6	6
Failure to Advance	6	6
Detachment of Device or Device Component	5	5
Positioning Failure	5	5
Obstruction of Flow	5	5
Contamination	5	5
Unintended Movement	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Defective Component	4	4
Insufficient Information	3	3
Device Dislodged or Dislocated	3	3
Unintended Deflation	3	3
Difficult to Insert	3	3
Failure to Unfold or Unwrap	3	3
Off-Label Use	3	3
Material Twisted/Bent	3	3
Use of Device Problem	3	3
Flaked	3	3
Appropriate Term/Code Not Available	2	2
No Apparent Adverse Event	2	2
Material Split, Cut or Torn	2	2
Failure to Eject	2	2
Device Damaged by Another Device	2	2
Air/Gas in Device	2	2
Positioning Problem	2	2
Material Integrity Problem	2	2
Device Contaminated During Manufacture or Shipping	2	2
Degraded	2	2
Improper Flow or Infusion	1	1
Human-Device Interface Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	624	624
No Known Impact Or Consequence To Patient	47	47
Vascular Dissection	38	38
No Consequences Or Impact To Patient	36	36
Insufficient Information	25	25
Perforation of Vessels	22	22
Intracranial Hemorrhage	21	21
Rupture	20	20
Thrombosis/Thrombus	19	19
Hemorrhage/Bleeding	19	19
Thrombus	15	15
Obstruction/Occlusion	13	13
Ruptured Aneurysm	10	10
Unspecified Nervous System Problem	9	9
Ischemia	9	9
Thromboembolism	8	8
Embolism/Embolus	7	7
Foreign Body In Patient	7	7
No Patient Involvement	7	7
Paresis	7	7
Ischemia Stroke	6	6
Hematoma	6	6
Stroke/CVA	6	6
Aneurysm	5	5
Fistula	4	4
Death	4	4
Vasoconstriction	4	4
Pulmonary Embolism	4	4
Foreign Body Embolism	3	3
Hemorrhagic Stroke	3	3
Hydrocephalus	3	3
Nervous System Injury	3	3
Dysphasia	3	3
Cognitive Changes	3	3
Neurological Deficit/Dysfunction	3	3
Muscle Weakness	3	3
Laceration(s)	3	3
Unintended Radiation Exposure	2	2
Swelling/ Edema	2	2
Great Vessel Perforation	2	2
Loss of Vision	2	2
Neurogenic Shock	2	2
Blurred Vision	2	2
Transient Ischemic Attack	2	2
Iatrogenic Source	2	2
Septic Shock	2	2
Extravasation	2	2
Foreign Body Reaction	2	2
Headache	2	2
Status Epilepticus	2	2