TPLC - Total Product Life Cycle

show TPLC since

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
PHILIPS IMAGE GUIDED THERAPY DEVICES
	SUBSTANTIALLY EQUIVALENT	1
PRYTIME MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	3
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	244	246
Inflation Problem	128	128
Adverse Event Without Identified Device or Use Problem	128	129
Leak/Splash	113	113
Fluid/Blood Leak	98	98
Deflation Problem	91	91
Burst Container or Vessel	65	65
Failure to Deflate	55	55
Material Puncture/Hole	53	53
Patient Device Interaction Problem	44	46
Break	36	38
Entrapment of Device	30	30
Material Deformation	30	30
Difficult to Remove	20	20
Fracture	12	12
Difficult to Open or Close	11	11
Difficult to Advance	10	10
Improper or Incorrect Procedure or Method	9	9
Physical Resistance/Sticking	9	9
Flaked	8	8
Thickening of Material	8	8
Detachment of Device or Device Component	8	8
Mechanical Problem	7	7
Unintended Deflation	7	7
Failure to Advance	6	6
Packaging Problem	6	6
Gas/Air Leak	6	6
Obstruction of Flow	6	6
Contamination	5	6
Positioning Failure	5	5
Material Split, Cut or Torn	4	4
Unintended Movement	4	4
Manufacturing, Packaging or Shipping Problem	4	4
No Apparent Adverse Event	4	4
Device Dislodged or Dislocated	3	3
Failure to Unfold or Unwrap	3	3
Insufficient Device Problem Information	3	3
Use of Device Problem	3	3
Difficult to Insert	3	3
Degraded	3	3
Positioning Problem	3	3
Defective Component	3	3
Off-Label Use	3	3
Material Twisted/Bent	2	2
Device Damaged by Another Device	2	2
Air/Gas in Device	2	2
Material Integrity Problem	2	2
Appropriate Device Problem Term/Code Not Available	2	2
Failure to Eject	2	2
Display or Visual Feedback Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	821	825
Vascular Dissection	52	54
No Known Impact Or Consequence To Patient	47	47
Perforation of Vessels	37	38
No Consequences Or Impact To Patient	36	36
Intracranial Hemorrhage	27	28
Insufficient Information	26	26
Thrombosis/Thrombus	25	25
Rupture	22	24
Hemorrhage/Blood Loss/Bleeding	21	21
Embolism/Embolus	16	16
Obstruction/Occlusion	16	16
Thrombus	15	15
Ischemia Stroke	12	12
Ruptured Aneurysm	11	13
Ischemia	11	11
Unspecified Nervous System Problem	10	10
Thromboembolism	9	9
Foreign Body In Patient	8	8
No Patient Involvement	7	7
Nervous System Injury	7	7
Paresis	7	7
Aneurysm	7	7
Stroke/CVA	6	6
Hematoma	6	6
Pulmonary Embolism	5	5
Hemorrhagic Stroke	5	5
Fistula	4	4
Death	4	4
Vasoconstriction	4	4
Hydrocephalus	4	4
Cognitive Changes	4	5
Foreign Body Embolism	3	3
Laceration(s)	3	3
Renal Impairment	3	3
Stenosis	3	3
Neurological Deficit/Dysfunction	3	3
Great Vessel Perforation	3	3
Pseudoaneurysm	3	3
Convulsion/Seizure	3	3
Headache	3	3
Brain Injury	3	3
Dysphasia	3	3
Muscle Weakness/Atrophy	3	3
Unspecified Tissue Injury	2	2
Swelling/ Edema	2	2
Blurred Vision	2	2
Extravasation	2	2
Loss of Vision	2	2
Cancer	2	2