TPLC - Total Product Life Cycle

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Device	catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Definition	To reduce coronary artery stenosis by dilatation of the balloon and by apposition of the cutting/scoring surfaces to the stenotic material for the treatment of coronary artery stenosis to improve myocardial perfusion.
Product Code	NWX
Device Class	3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
4	2	5	1	4	0	0	8	9	6	7	15	7	16	13	5

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Rupture	4312	4434
Break	432	432
Failure to Advance	300	300
Difficult to Remove	191	191
Detachment of Device or Device Component	166	166
Entrapment of Device	139	139
Inflation Problem	120	120
Leak/Splash	115	115
Material Deformation	114	114
Adverse Event Without Identified Device or Use Problem	114	114
Material Integrity Problem	83	83
Difficult to Advance	72	72
Detachment Of Device Component	63	63
Device Dislodged or Dislocated	49	49
Deflation Problem	36	36
Device Damaged Prior to Use	23	23
Material Puncture/Hole	20	20
Physical Resistance/Sticking	17	17
Fracture	15	15
Material Separation	14	14
Material Twisted/Bent	14	14
Fluid/Blood Leak	12	12
Kinked	10	10
Difficult to Insert	10	10
Device-Device Incompatibility	9	9
Failure to Deflate	8	8
Stretched	8	8
Device Contamination with Chemical or Other Material	7	7
Device Markings/Labelling Problem	6	6
Defective Device	6	6
Contamination	6	6
Hole In Material	5	5
Unsealed Device Packaging	5	5
Device Damaged by Another Device	4	4
Retraction Problem	4	4
Sticking	4	4
Material Split, Cut or Torn	4	4
Physical Resistance	3	3
Bent	3	3
Defective Component	3	3
Peeled/Delaminated	3	3
Inadequacy of Device Shape and/or Size	3	3
Difficult to Open or Remove Packaging Material	3	3
Burst Container or Vessel	3	3
Improper or Incorrect Procedure or Method	3	3
Unraveled Material	2	2
Use of Device Problem	2	2
Material Perforation	2	2
Sharp Edges	2	2
Torn Material	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2863	2985
No Consequences Or Impact To Patient	2639	2639
No Patient Involvement	92	92
No Known Impact Or Consequence To Patient	45	45
Vascular Dissection	33	33
Foreign Body In Patient	33	33
Device Embedded In Tissue or Plaque	26	26
Perforation of Vessels	18	18
Atherosclerosis	17	17
No Code Available	16	16
Ischemic Heart Disease	14	14
Obstruction/Occlusion	7	7
Intimal Dissection	6	6
No Information	6	6
Perforation	6	6
Injury	5	5
Death	4	4
Ischemia	4	4
Chest Pain	4	4
Pericardial Effusion	4	4
Cardiac Arrest	4	4
Low Blood Pressure/ Hypotension	3	3
Insufficient Information	3	3
Embolism/Embolus	3	3
Hematoma	3	3
Cardiac Tamponade	2	2
Chest Tightness/Pressure	2	2
Angina	2	2
Thrombosis/Thrombus	2	2
Peripheral Vascular Disease	2	2
Cardiogenic Shock	2	2
Bradycardia	2	2
Shock	2	2
Embolism	2	2
Unspecified Heart Problem	2	2
Atrial Perforation	2	2
ST Segment Elevation	2	2
Patient Problem/Medical Problem	2	2
Vasoconstriction	1	1
Cardiac Perforation	1	1
Respiratory Arrest	1	1
Thrombosis	1	1
Discomfort	1	1
Cardiopulmonary Arrest	1	1
Pneumonia	1	1
Complaint, Ill-Defined	1	1
Calcium Deposits/Calcification	1	1
Myocardial Infarction	1	1
Tissue Damage	1	1
Therapeutic Response, Decreased	1	1