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	176	176
Inflation Problem	101	101
Adverse Event Without Identified Device or Use Problem	97	97
Deflation Problem	78	78
Leak/Splash	76	76
Fluid/Blood Leak	76	76
Failure to Deflate	49	49
Material Puncture/Hole	43	43
Burst Container or Vessel	40	40
Break	34	34
Entrapment of Device	27	27
Patient Device Interaction Problem	21	21
Difficult to Remove	17	17
Difficult to Open or Close	11	11
Fracture	10	10
Material Deformation	9	9
Improper or Incorrect Procedure or Method	8	8
Physical Resistance/Sticking	8	8
Mechanical Problem	7	7
Failure to Advance	6	6
Difficult to Advance	5	5
Detachment of Device or Device Component	5	5
Contamination	5	5
Gas/Air Leak	5	5
Positioning Failure	5	5
Obstruction of Flow	5	5
Defective Component	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Flaked	3	3
Off-Label Use	3	3
Insufficient Information	3	3
Device Dislodged or Dislocated	3	3
Unintended Deflation	3	3
Failure to Unfold or Unwrap	3	3
Difficult to Insert	3	3
Material Twisted/Bent	3	3
Use of Device Problem	3	3
Appropriate Term/Code Not Available	2	2
No Apparent Adverse Event	2	2
Device Damaged by Another Device	2	2
Failure to Eject	2	2
Material Split, Cut or Torn	2	2
Device Contaminated During Manufacture or Shipping	2	2
Stretched	1	1
Material Fragmentation	1	1
Component Missing	1	1
Improper Flow or Infusion	1	1
Degraded	1	1
Air/Gas in Device	1	1
Insufficient Flow or Under Infusion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	586	586
No Known Impact Or Consequence To Patient	47	47
Vascular Dissection	37	37
No Consequences Or Impact To Patient	36	36
Insufficient Information	25	25
Intracranial Hemorrhage	21	21
Rupture	20	20
Thrombosis/Thrombus	19	19
Hemorrhage/Bleeding	19	19
Perforation of Vessels	17	17
Thrombus	15	15
Obstruction/Occlusion	13	13
Ruptured Aneurysm	10	10
Unspecified Nervous System Problem	9	9
Thromboembolism	8	8
Ischemia	8	8
No Patient Involvement	7	7
Paresis	7	7
Stroke/CVA	6	6
Ischemia Stroke	6	6
Hematoma	6	6
Embolism/Embolus	6	6
Foreign Body In Patient	6	6
Aneurysm	5	5
Death	4	4
Fistula	4	4
Pulmonary Embolism	4	4
Vasoconstriction	4	4
Foreign Body Embolism	3	3
Laceration(s)	3	3
Hydrocephalus	3	3
Neurological Deficit/Dysfunction	3	3
Hemorrhagic Stroke	3	3
Cognitive Changes	3	3
Muscle Weakness	3	3
Nervous System Injury	3	3
Dysphasia	3	3
Great Vessel Perforation	2	2
Blurred Vision	2	2
Pseudoaneurysm	2	2
Headache	2	2
Swelling/ Edema	2	2
Extravasation	2	2
Loss of Vision	2	2
Cancer	2	2
Status Epilepticus	2	2
Cerebral Edema	2	2
Unintended Radiation Exposure	2	2
Neurogenic Shock	2	2
Septic Shock	2	2