TPLC - Total Product Life Cycle

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Device	catheter, percutaneous, neurovasculature
Regulation Description	Percutaneous catheter.
Definition	To provide vascular access to the neurovasculature for interventional or diagnostic procedures
Product Code	QJP
Regulation Number	870.1250
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Physical Resistance/Sticking	773	773
Adverse Event Without Identified Device or Use Problem	242	244
Retraction Problem	196	196
Material Twisted/Bent	107	107
Crack	89	89
Difficult to Advance	80	80
Material Deformation	79	79
Break	69	69
Unintended Movement	39	39
Material Separation	35	35
Burst Container or Vessel	28	28
No Apparent Adverse Event	28	28
Deformation Due to Compressive Stress	23	23
Fluid/Blood Leak	23	23
Stretched	22	22
Difficult to Remove	21	21
Fracture	19	19
Device Damaged by Another Device	14	14
Deflation Problem	13	13
Material Integrity Problem	10	10
Material Too Soft/Flexible	9	9
Insufficient Device Problem Information	9	9
Packaging Problem	9	9
Inflation Problem	8	8
Device Dislodged or Dislocated	7	7
Device-Device Incompatibility	7	7
Leak/Splash	6	6
Peeled/Delaminated	6	6
Failure to Advance	5	5
Failure to Deflate	5	5
Collapse	5	5
Product Quality Problem	5	5
Material Split, Cut or Torn	4	4
Wrong Label	4	4
Unsealed Device Packaging	4	4
Compatibility Problem	3	3
Flaked	3	3
Material Puncture/Hole	3	3
Component or Accessory Incompatibility	3	3
Contamination /Decontamination Problem	3	3
Material Rupture	2	2
Patient-Device Incompatibility	2	2
Use of Device Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Defective Component	1	1
Incomplete or Missing Packaging	1	1
Expiration Date Error	1	1
Malposition of Device	1	1
Air/Gas in Device	1	1
Difficult or Delayed Positioning	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1258	1258
Intracranial Hemorrhage	75	76
Ischemia Stroke	59	60
Obstruction/Occlusion	34	35
Vascular Dissection	33	34
Headache	32	32
Vasoconstriction	31	31
Thromboembolism	27	27
Hemorrhage/Blood Loss/Bleeding	23	23
Hematoma	21	21
Embolism/Embolus	20	20
Aneurysm	18	18
Hemorrhagic Stroke	18	19
Swelling/ Edema	18	18
Foreign Body In Patient	18	18
Ischemia	15	15
Stroke/CVA	15	16
Pain	13	13
Paresis	13	13
Unspecified Nervous System Problem	13	13
Cerebral Edema	12	13
Bacterial Infection	12	12
Nervous System Injury	12	12
Perforation of Vessels	12	12
Ruptured Aneurysm	11	12
Visual Disturbances	10	10
Dysphasia	10	10
Transient Ischemic Attack	10	10
Stenosis	10	10
Perforation	9	9
Thrombosis/Thrombus	8	8
Rupture	8	8
Bruise/Contusion	7	7
Fistula	7	7
Insufficient Information	7	7
Foreign Body Reaction	6	6
Diplopia/Double Vision	6	6
Confusion/ Disorientation	6	6
Blurred Vision	5	5
Muscle Weakness/Atrophy	5	5
Paralysis	5	5
Nausea	5	5
Skin Discoloration	5	5
Low Blood Pressure/ Hypotension	4	4
Inflammation	4	4
Cardiac Arrest	4	4
Pseudoaneurysm	4	4
Speech Disorder	4	4
Respiratory Insufficiency	4	4
Hypokalemia	3	3