TPLC - Total Product Life Cycle

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Device	temporary carotid catheter for embolic capture
Regulation Description	Percutaneous catheter.
Definition	This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i
Product Code	NTE
Regulation Number	870.1250
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	891	891
Material Separation	213	213
Difficult to Remove	195	195
Retraction Problem	130	130
Detachment of Device or Device Component	129	129
Break	119	119
Difficult to Insert	107	107
Improper or Incorrect Procedure or Method	101	101
Difficult to Advance	82	82
Deformation Due to Compressive Stress	78	78
Material Split, Cut or Torn	56	56
Stretched	55	55
Entrapment of Device	46	46
Activation Failure	43	43
Migration	40	40
Material Twisted/Bent	39	39
Material Deformation	37	37
Failure to Advance	33	33
Material Integrity Problem	30	30
Fracture	30	30
Device Dislodged or Dislocated	29	29
Off-Label Use	23	23
Device Damaged by Another Device	21	21
Difficult or Delayed Positioning	18	18
Use of Device Problem	17	17
Unraveled Material	15	15
Deflation Problem	13	13
Contamination /Decontamination Problem	13	13
Device Difficult to Setup or Prepare	13	13
Burst Container or Vessel	12	12
Defective Component	11	11
Material Too Soft/Flexible	10	10
Device Contamination with Chemical or Other Material	8	8
Peeled/Delaminated	8	8
Activation, Positioning or Separation Problem	8	8
Product Quality Problem	7	7
Inflation Problem	7	7
Positioning Problem	6	6
Physical Resistance/Sticking	6	6
Leak/Splash	6	6
Premature Activation	6	6
Device Markings/Labelling Problem	5	5
Device Misassembled During Manufacturing /Shipping	4	4
Component Missing	4	4
Device-Device Incompatibility	4	4
No Apparent Adverse Event	3	3
Infusion or Flow Problem	3	3
Patient Device Interaction Problem	3	3
Defective Device	3	3
Insufficient Information	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	619	619
Vascular Dissection	568	568
No Consequences Or Impact To Patient	176	176
Stroke/CVA	149	149
Ischemia Stroke	120	120
Patient Problem/Medical Problem	85	85
Brain Injury	49	49
Embolism/Embolus	49	49
Insufficient Information	41	41
Foreign Body In Patient	39	39
Muscle Weakness	37	37
Thrombosis/Thrombus	36	36
Transient Ischemic Attack	36	36
No Patient Involvement	32	32
Myocardial Infarction	32	32
Obstruction/Occlusion	31	31
Hematoma	21	21
Perforation	20	20
Embolism	20	20
Unspecified Tissue Injury	18	18
Low Blood Pressure/ Hypotension	17	17
Bradycardia	16	16
Hemorrhage/Bleeding	14	14
Pseudoaneurysm	14	14
Device Embedded In Tissue or Plaque	13	13
Thrombosis	13	13
Injury	13	13
Dysphasia	12	12
Occlusion	12	12
Perforation of Vessels	11	11
Intracranial Hemorrhage	11	11
No Known Impact Or Consequence To Patient	10	10
Vasoconstriction	9	9
Infarction, Cerebral	8	8
Intimal Dissection	8	8
Reocclusion	7	7
Extravasation	7	7
Thrombus	7	7
Death	7	7
Restenosis	7	7
Weakness	6	6
Renal Failure	6	6
Pain	6	6
Blood Loss	5	5
Ischemia	5	5
Nerve Damage	5	5
Numbness	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Paresis	5	5
Hemorrhagic Stroke	4	4