TPLC - Total Product Life Cycle

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Device	temporary carotid catheter for embolic capture
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	816	816
Material Separation	191	191
Difficult to Remove	181	181
Detachment of Device or Device Component	118	118
Retraction Problem	113	113
Break	106	106
Difficult to Insert	92	92
Improper or Incorrect Procedure or Method	83	83
Difficult to Advance	71	71
Deformation Due to Compressive Stress	69	69
Material Split, Cut or Torn	48	48
Stretched	46	46
Entrapment of Device	43	43
Activation Failure	42	42
Material Deformation	35	35
Migration	34	34
Material Twisted/Bent	31	31
Failure to Advance	30	30
Fracture	28	28
Material Integrity Problem	28	28
Off-Label Use	23	23
Device Damaged by Another Device	18	18
Device Dislodged or Dislocated	17	17
Use of Device Problem	15	15
Difficult or Delayed Positioning	14	14
Deflation Problem	13	13
Device Difficult to Setup or Prepare	13	13
Contamination /Decontamination Problem	12	12
Unraveled Material	12	12
Burst Container or Vessel	11	11
Device Contamination with Chemical or Other Material	8	8
Peeled/Delaminated	8	8
Material Too Soft/Flexible	8	8
Activation, Positioning or Separation Problem	8	8
Defective Component	7	7
Product Quality Problem	7	7
Inflation Problem	7	7
Positioning Problem	6	6
Physical Resistance/Sticking	6	6
Leak/Splash	6	6
Device Markings/Labelling Problem	5	5
Premature Activation	5	5
Component Missing	4	4
Defective Device	3	3
Insufficient Information	3	3
Patient Device Interaction Problem	3	3
Device Misassembled During Manufacturing /Shipping	3	3
No Apparent Adverse Event	3	3
Device-Device Incompatibility	3	3
Infusion or Flow Problem	3	3

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	528	528
Vascular Dissection	515	515
No Consequences Or Impact To Patient	176	176
Stroke/CVA	136	136
Ischemia Stroke	107	107
Patient Problem/Medical Problem	85	85
Brain Injury	48	48
Embolism/Embolus	40	40
Insufficient Information	38	38
Foreign Body In Patient	33	33
Transient Ischemic Attack	33	33
No Patient Involvement	32	32
Thrombosis/Thrombus	31	31
Myocardial Infarction	28	28
Obstruction/Occlusion	25	25
Muscle Weakness	23	23
Embolism	20	20
Hematoma	20	20
Perforation	18	18
Unspecified Tissue Injury	17	17
Low Blood Pressure/ Hypotension	14	14
Bradycardia	13	13
Thrombosis	13	13
Injury	13	13
Pseudoaneurysm	13	13
Occlusion	12	12
Hemorrhage/Bleeding	12	12
Device Embedded In Tissue or Plaque	12	12
No Known Impact Or Consequence To Patient	10	10
Intracranial Hemorrhage	10	10
Perforation of Vessels	9	9
Vasoconstriction	8	8
Infarction, Cerebral	8	8
Intimal Dissection	8	8
Dysphasia	8	8
Thrombus	7	7
Death	7	7
Reocclusion	7	7
Restenosis	7	7
Extravasation	6	6
Weakness	6	6
Pain	6	6
Ischemia	5	5
Blood Loss	5	5
Renal Failure	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Numbness	5	5
Nerve Damage	5	5
Thromboembolism	4	4
Hemorrhagic Stroke	4	4