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	187	187
Inflation Problem	122	122
Adverse Event Without Identified Device or Use Problem	107	107
Deflation Problem	105	105
Fluid/Blood Leak	84	84
Leak/Splash	74	74
Burst Container or Vessel	49	49
Material Puncture/Hole	48	48
Failure to Deflate	47	47
Break	36	36
Entrapment of Device	27	27
Difficult to Remove	17	17
Patient Device Interaction Problem	13	13
Difficult to Open or Close	11	11
Fracture	11	11
Material Deformation	11	11
Improper or Incorrect Procedure or Method	8	8
Physical Resistance/Sticking	8	8
Mechanical Problem	6	6
Failure to Advance	6	6
Detachment of Device or Device Component	6	6
Contamination	6	6
Flaked	5	5
Material Integrity Problem	5	5
Material Perforation	5	5
Gas/Air Leak	5	5
Obstruction of Flow	5	5
Positioning Failure	5	5
Difficult to Advance	4	4
Defective Component	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Appropriate Term/Code Not Available	3	3
Device Dislodged or Dislocated	3	3
Failure to Unfold or Unwrap	3	3
Device Damaged by Another Device	3	3
Use of Device Problem	3	3
Difficult to Insert	3	3
Off-Label Use	3	3
Insufficient Information	3	3
Unintended Deflation	3	3
Device Contaminated During Manufacture or Shipping	2	2
Failure to Eject	2	2
No Apparent Adverse Event	2	2
Tear, Rip or Hole in Device Packaging	2	2
Positioning Problem	2	2
Material Twisted/Bent	2	2
Component Missing	2	2
Improper Flow or Infusion	1	1
Therapeutic or Diagnostic Output Failure	1	1
Defective Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	560	560
No Known Impact Or Consequence To Patient	108	108
No Consequences Or Impact To Patient	82	82
Vascular Dissection	32	32
Insufficient Information	25	25
Intracranial Hemorrhage	23	23
Rupture	22	22
Thrombosis/Thrombus	19	19
Hemorrhage/Bleeding	18	18
Perforation of Vessels	18	18
No Patient Involvement	18	18
Thrombus	17	17
Obstruction/Occlusion	13	13
Death	11	11
Ruptured Aneurysm	10	10
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
Fistula	3	3
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
Dysphasia	3	3
Hemorrhagic Stroke	3	3
Blood Loss	3	3
Cognitive Changes	3	3
Muscle Weakness	3	3
Unintended Radiation Exposure	2	2
Cerebral Edema	2	2
Infarction, Cerebral	2	2
Status Epilepticus	2	2
Cancer	2	2
No Code Available	2	2
Ascites	2	2
Loss of Vision	2	2
Headache	2	2