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
PHILIPS IMAGE GUIDED THERAPY DEVICES
	SUBSTANTIALLY EQUIVALENT	1
PRYTIME MEDICAL DEVICES, INC
	SUBSTANTIALLY EQUIVALENT	1
PRYTIME MEDICAL DEVICES, INC.
	SUBSTANTIALLY EQUIVALENT	2
RENALPRO MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
RENOVORX, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPECTRANETICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
1. K203540 Bridge Occlusion Balloon
ZIEN MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	214	214
Inflation Problem	113	113
Adverse Event Without Identified Device or Use Problem	105	105
Leak/Splash	88	88
Fluid/Blood Leak	86	86
Deflation Problem	81	81
Burst Container or Vessel	57	57
Failure to Deflate	52	52
Material Puncture/Hole	48	48
Break	37	37
Patient Device Interaction Problem	32	32
Entrapment of Device	29	29
Difficult to Remove	18	18
Material Deformation	14	14
Fracture	12	12
Difficult to Open or Close	11	11
Physical Resistance/Sticking	8	8
Improper or Incorrect Procedure or Method	8	8
Thickening of Material	8	8
Mechanical Problem	7	7
Difficult to Advance	6	6
Failure to Advance	6	6
Gas/Air Leak	6	6
Obstruction of Flow	6	6
Detachment of Device or Device Component	5	5
Unintended Deflation	5	5
Flaked	5	5
Contamination	5	5
Positioning Failure	5	5
Material Split, Cut or Torn	4	4
Unintended Movement	4	4
Defective Component	4	4
Manufacturing, Packaging or Shipping Problem	4	4
Failure to Unfold or Unwrap	3	3
No Apparent Adverse Event	3	3
Packaging Problem	3	3
Device Dislodged or Dislocated	3	3
Material Twisted/Bent	3	3
Use of Device Problem	3	3
Difficult to Insert	3	3
Insufficient Information	3	3
Off-Label Use	3	3
Appropriate Term/Code Not Available	2	2
Degraded	2	2
Device Damaged by Another Device	2	2
Air/Gas in Device	2	2
Positioning Problem	2	2
Material Integrity Problem	2	2
Failure to Eject	2	2
Device Contaminated During Manufacture or Shipping	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	689	689
No Known Impact Or Consequence To Patient	47	47
Vascular Dissection	41	41
No Consequences Or Impact To Patient	36	36
Insufficient Information	26	26
Perforation of Vessels	25	25
Intracranial Hemorrhage	23	23
Thrombosis/Thrombus	22	22
Rupture	21	21
Hemorrhage/Bleeding	20	20
Obstruction/Occlusion	16	16
Thrombus	15	15
Ruptured Aneurysm	10	10
Unspecified Nervous System Problem	10	10
Ischemia Stroke	9	9
Ischemia	9	9
Thromboembolism	8	8
No Patient Involvement	7	7
Foreign Body In Patient	7	7
Embolism/Embolus	7	7
Paresis	7	7
Stroke/CVA	6	6
Hematoma	6	6
Nervous System Injury	5	5
Aneurysm	5	5
Fistula	4	4
Death	4	4
Pulmonary Embolism	4	4
Vasoconstriction	4	4
Cognitive Changes	4	4
Hemorrhagic Stroke	4	4
Hydrocephalus	4	4
Dysphasia	3	3
Foreign Body Embolism	3	3
Laceration(s)	3	3
Muscle Weakness	3	3
Neurological Deficit/Dysfunction	3	3
Extravasation	2	2
Stenosis	2	2
Unspecified Tissue Injury	2	2
Swelling/ Edema	2	2
Blurred Vision	2	2
Great Vessel Perforation	2	2
Pseudoaneurysm	2	2
Headache	2	2
Loss of Vision	2	2
Cancer	2	2
Status Epilepticus	2	2
Cerebral Edema	2	2
Unintended Radiation Exposure	2	2