TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, intravascular occluding, temporary
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
BALT USA, 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
QXMEDICAL, LLC
	SUBSTANTIALLY EQUIVALENT	1
RENALPRO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RENOVORX, INC.
	SUBSTANTIALLY EQUIVALENT	2
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	164	164
Inflation Problem	118	118
Adverse Event Without Identified Device or Use Problem	105	105
Deflation Problem	101	101
Fluid/Blood Leak	80	80
Leak/Splash	68	68
Material Puncture/Hole	47	47
Burst Container or Vessel	44	44
Failure to Deflate	41	41
Break	36	36
Entrapment of Device	27	27
Difficult to Remove	16	16
Difficult to Open or Close	11	11
Fracture	10	10
Material Deformation	8	8
Improper or Incorrect Procedure or Method	7	7
Physical Resistance/Sticking	7	7
Mechanical Problem	6	6
Failure to Advance	6	6
Detachment of Device or Device Component	6	6
Material Integrity Problem	6	6
Patient Device Interaction Problem	6	6
Flaked	5	5
Material Perforation	5	5
Gas/Air Leak	5	5
Obstruction of Flow	5	5
Contamination	5	5
Defective Component	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Positioning Failure	4	4
Appropriate Term/Code Not Available	3	3
Device Damaged by Another Device	3	3
Use of Device Problem	3	3
Off-Label Use	3	3
Unintended Deflation	3	3
Insufficient Information	3	3
Difficult to Advance	3	3
Device Contaminated During Manufacture or Shipping	2	2
Difficult to Insert	2	2
Component Missing	2	2
Material Twisted/Bent	2	2
Positioning Problem	2	2
Device Dislodged or Dislocated	2	2
Failure to Eject	2	2
Material Separation	2	2
Tear, Rip or Hole in Device Packaging	2	2
No Apparent Adverse Event	2	2
No Flow	1	1
Display or Visual Feedback Problem	1	1
Device Slipped	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	510	510
No Known Impact Or Consequence To Patient	108	108
No Consequences Or Impact To Patient	82	82
Vascular Dissection	26	26
Insufficient Information	24	24
Rupture	22	22
Intracranial Hemorrhage	22	22
Thrombosis/Thrombus	19	19
No Patient Involvement	18	18
Thrombus	17	17
Hemorrhage/Bleeding	15	15
Perforation of Vessels	14	14
Obstruction/Occlusion	13	13
Death	11	11
Ruptured Aneurysm	9	9
Paresis	9	9
Unspecified Nervous System Problem	9	9
Stroke/CVA	8	8
Thromboembolism	8	8
Ischemia	8	8
Foreign Body In Patient	7	7
Neurological Deficit/Dysfunction	7	7
Ischemia Stroke	6	6
Hematoma	6	6
Aneurysm	5	5
Embolism/Embolus	5	5
Pulmonary Embolism	4	4
Vasoconstriction	4	4
Nervous System Injury	3	3
Hemorrhage, Subarachnoid	3	3
Vascular System (Circulation), Impaired	3	3
Hydrocephalus	3	3
Laceration(s)	3	3
Foreign Body Embolism	3	3
Iatrogenic Source	3	3
Hemorrhagic Stroke	3	3
Blood Loss	3	3
Cognitive Changes	3	3
Muscle Weakness	3	3
Dysphasia	3	3
Transient Ischemic Attack	2	2
Foreign Body Reaction	2	2
Paralysis	2	2
Cardiac Perforation	2	2
Pericardial Effusion	2	2
Septic Shock	2	2
Neurogenic Shock	2	2
Hemorrhage, Cerebral	2	2
Unintended Radiation Exposure	2	2
Cerebral Edema	2	2