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	849	849
Material Separation	206	206
Difficult to Remove	186	186
Retraction Problem	120	120
Detachment of Device or Device Component	113	113
Break	109	109
Improper or Incorrect Procedure or Method	104	104
Difficult to Insert	101	101
Difficult to Advance	83	83
Deformation Due to Compressive Stress	79	79
Material Split, Cut or Torn	55	55
Stretched	52	52
Entrapment of Device	45	45
Activation Failure	42	42
Material Twisted/Bent	42	42
Failure to Advance	35	35
Migration	33	33
Device Dislodged or Dislocated	31	31
Material Deformation	30	30
Material Integrity Problem	28	28
Fracture	25	25
Device Damaged by Another Device	19	19
Difficult or Delayed Positioning	19	19
Use of Device Problem	17	17
Unraveled Material	13	13
Device Difficult to Setup or Prepare	13	13
Off-Label Use	13	13
Contamination /Decontamination Problem	11	11
Material Too Soft/Flexible	10	10
Burst Container or Vessel	9	9
Deflation Problem	8	8
Peeled/Delaminated	8	8
Device Contamination with Chemical or Other Material	8	8
Defective Component	7	7
Inflation Problem	7	7
Leak/Splash	7	7
Activation, Positioning or Separation Problem	6	6
Positioning Problem	5	5
Device Markings/Labelling Problem	5	5
Physical Resistance/Sticking	5	5
Device-Device Incompatibility	5	5
Premature Activation	5	5
Device Misassembled During Manufacturing /Shipping	4	4
Product Quality Problem	3	3
Component Missing	3	3
Defective Device	3	3
Material Frayed	3	3
Infusion or Flow Problem	2	2
No Apparent Adverse Event	2	2
Insufficient Information	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	673	673
Vascular Dissection	550	550
Stroke/CVA	149	149
Ischemia Stroke	133	133
No Consequences Or Impact To Patient	82	82
Embolism/Embolus	56	56
Muscle Weakness	46	46
Insufficient Information	41	41
Foreign Body In Patient	40	40
Brain Injury	39	39
Thrombosis/Thrombus	38	38
Obstruction/Occlusion	35	35
Patient Problem/Medical Problem	31	31
Myocardial Infarction	29	29
Transient Ischemic Attack	28	28
Perforation	20	20
Hematoma	20	20
Unspecified Tissue Injury	17	17
No Patient Involvement	16	16
Low Blood Pressure/ Hypotension	14	14
Bradycardia	13	13
Vasoconstriction	13	13
Dysphasia	13	13
Device Embedded In Tissue or Plaque	12	12
Hemorrhage/Bleeding	12	12
Intracranial Hemorrhage	11	11
Pseudoaneurysm	11	11
Perforation of Vessels	10	10
Restenosis	9	9
Embolism	9	9
Extravasation	7	7
Injury	7	7
Pain	6	6
Occlusion	5	5
Intimal Dissection	5	5
Renal Failure	5	5
Blood Loss	5	5
Hemorrhagic Stroke	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	5	5
Paralysis	5	5
Nerve Damage	5	5
Reocclusion	4	4
Paresis	4	4
Numbness	4	4
Ischemia	4	4
Death	4	4
High Blood Pressure/ Hypertension	4	4
Thrombosis	3	3
No Known Impact Or Consequence To Patient	3	3
Respiratory Failure	3	3