TPLC - Total Product Life Cycle

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Device	temporary coronary saphenous vein bypass graft for embolic protection
Regulation Description	Percutaneous catheter.
Product Code	NFA
Regulation Number	870.1250
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Integrity Problem	100	100
Difficult to Remove	96	96
Adverse Event Without Identified Device or Use Problem	48	48
Difficult or Delayed Positioning	22	22
Nonstandard Device	13	13
Difficult to Advance	12	12
Failure to Advance	9	9
Mechanical Problem	6	6
Mechanical Jam	6	6
Device-Device Incompatibility	4	4
Device Difficult to Setup or Prepare	3	3
Material Split, Cut or Torn	2	2
Break	2	2
Entrapment of Device	2	2
Defective Device	2	2
Positioning Problem	2	2
Contamination	2	2
Difficult or Delayed Activation	2	2
Detachment of Device or Device Component	2	2
Device Contamination with Chemical or Other Material	2	2
Deformation Due to Compressive Stress	2	2
Activation, Positioning or Separation Problem	1	1
Migration or Expulsion of Device	1	1
Difficult to Open or Remove Packaging Material	1	1
Device Markings/Labelling Problem	1	1
Unsealed Device Packaging	1	1
Device Damaged by Another Device	1	1
Retraction Problem	1	1
Material Separation	1	1
Activation Failure	1	1
Fracture	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	204	204
Insufficient Information	6	6
Stroke/CVA	5	5
Transient Ischemic Attack	5	5
Vasoconstriction	4	4
Embolism/Embolus	4	4
Foreign Body In Patient	4	4
Myocardial Infarction	4	4
High Blood Pressure/ Hypertension	3	3
Obstruction/Occlusion	3	3
Bradycardia	2	2
No Consequences Or Impact To Patient	2	2
Low Blood Pressure/ Hypotension	2	2
Ischemia Stroke	2	2
Dysphasia	1	1
Hematoma	1	1
Intracranial Hemorrhage	1	1
Paralysis	1	1
Nerve Damage	1	1
Coma	1	1
Perforation of Vessels	1	1
Stenosis	1	1
Loss of Vision	1	1