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	876	876
Difficult to Remove	252	252
Material Separation	229	229
Retraction Problem	132	132
Detachment of Device or Device Component	129	130
Break	122	122
Difficult to Insert	116	116
Improper or Incorrect Procedure or Method	114	114
Difficult to Advance	97	97
Deformation Due to Compressive Stress	85	85
Stretched	84	84
Material Split, Cut or Torn	56	56
Material Twisted/Bent	53	53
Device Dislodged or Dislocated	44	44
Failure to Advance	43	43
Activation Failure	43	43
Entrapment of Device	42	42
Material Deformation	41	41
Migration	35	35
Unraveled Material	30	30
Material Integrity Problem	30	30
Difficult or Delayed Positioning	21	21
Fracture	20	20
Device Difficult to Setup or Prepare	14	14
Use of Device Problem	14	14
Defective Component	13	13
Contamination /Decontamination Problem	12	12
Device Damaged by Another Device	12	12
Off-Label Use	12	12
Material Too Soft/Flexible	10	10
Premature Activation	7	7
Activation, Positioning or Separation Problem	7	7
Device Contamination with Chemical or Other Material	7	7
Burst Container or Vessel	7	7
Peeled/Delaminated	6	6
Physical Resistance/Sticking	6	6
Inflation Problem	6	6
Deflation Problem	5	5
Device Markings/Labelling Problem	5	5
Device-Device Incompatibility	5	5
Defective Device	4	4
Positioning Problem	4	4
Material Frayed	4	4
Device Misassembled During Manufacturing /Shipping	4	4
Difficult or Delayed Activation	4	4
Leak/Splash	3	3
Air/Gas in Device	3	3
Component Missing	3	3
Product Quality Problem	3	3
Connection Problem	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	879	880
Vascular Dissection	559	559
Ischemia Stroke	167	167
Stroke/CVA	163	163
Muscle Weakness	72	72
Embolism/Embolus	68	68
Insufficient Information	64	64
Thrombosis/Thrombus	46	46
Foreign Body In Patient	44	44
Obstruction/Occlusion	40	40
Transient Ischemic Attack	39	39
Myocardial Infarction	37	37
Hematoma	29	29
Low Blood Pressure/ Hypotension	23	23
Device Embedded In Tissue or Plaque	21	21
Perforation	20	20
Dysphasia	18	18
Unspecified Tissue Injury	17	17
Hemorrhage/Bleeding	16	16
Bradycardia	15	15
Brain Injury	14	14
Restenosis	13	13
Intracranial Hemorrhage	13	13
Vasoconstriction	13	13
Paralysis	12	12
Perforation of Vessels	12	12
High Blood Pressure/ Hypertension	10	10
Speech Disorder	9	9
Hemorrhagic Stroke	8	8
Pseudoaneurysm	7	7
Extravasation	7	7
Loss of Vision	6	6
Renal Failure	6	6
No Consequences Or Impact To Patient	5	5
Nerve Damage	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Ischemia	4	4
Swelling/ Edema	4	4
Thromboembolism	4	4
Pain	4	4
Convulsion/Seizure	3	3
Stenosis	3	3
Respiratory Failure	3	3
Nervous System Injury	3	3
Pulmonary Embolism	3	3
Numbness	3	3
Paresis	3	3
Unspecified Heart Problem	2	2
Dysphagia/ Odynophagia	2	2
Calcium Deposits/Calcification	2	2