TPLC - Total Product Life Cycle

show TPLC since

Device	catheter, coronary, atherectomy
Product Code	MCX
Device Class	3

Premarket Approvals (PMA)
2020	2021	2022	2023	2024	2025
20	9	12	18	9	10

Device Problems	MDRs with this Device Problem	Events in those MDRs
Entrapment of Device	1246	1246
Adverse Event Without Identified Device or Use Problem	975	975
Material Separation	586	586
Output Problem	447	447
Detachment of Device or Device Component	428	428
Difficult to Remove	195	196
Device Damaged by Another Device	189	189
Intermittent Loss of Power	184	184
Material Deformation	153	153
Material Integrity Problem	143	143
Failure to Advance	140	140
Fracture	129	131
Mechanical Problem	114	114
Unintended System Motion	106	106
Display or Visual Feedback Problem	90	90
Noise, Audible	89	89
Break	84	86
Difficult to Advance	80	80
Unstable	67	67
Defective Device	67	67
Mechanical Jam	64	64
Leak/Splash	59	59
Physical Resistance/Sticking	53	53
Device Contamination with Chemical or Other Material	52	52
Gas/Air Leak	50	50
No Display/Image	48	48
Fluid/Blood Leak	43	43
Material Split, Cut or Torn	41	41
Improper or Incorrect Procedure or Method	38	38
Positioning Problem	36	36
Contamination	29	29
Device-Device Incompatibility	28	28
Unexpected Shutdown	21	21
Stretched	17	17
Material Twisted/Bent	17	17
Insufficient Information	15	15
Unsealed Device Packaging	15	15
Suction Problem	14	14
Connection Problem	12	12
Device Contamination with Body Fluid	9	9
Off-Label Use	8	8
Unintended Movement	8	8
Device Remains Activated	8	8
Difficult to Insert	7	7
Difficult to Open or Close	6	6
Deformation Due to Compressive Stress	6	6
Packaging Problem	6	6
Difficult or Delayed Activation	6	6
Device Markings/Labelling Problem	5	6
Failure to Prime	5	5

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2346	2348
Foreign Body In Patient	657	658
Perforation of Vessels	465	465
No Consequences Or Impact To Patient	438	438
Vascular Dissection	269	269
Low Blood Pressure/ Hypotension	150	150
Device Embedded In Tissue or Plaque	122	122
Myocardial Infarction	116	116
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	96	96
Perforation	93	93
Cardiac Arrest	88	88
Chest Pain	81	81
Insufficient Information	65	66
No Known Impact Or Consequence To Patient	62	62
Obstruction/Occlusion	54	54
Cardiac Tamponade	48	48
Hematoma	42	42
Bradycardia	39	39
Pericardial Effusion	39	39
Death	38	38
Hemorrhage/Bleeding	35	35
Arrhythmia	33	33
Non specific EKG/ECG Changes	31	31
Thrombosis/Thrombus	30	30
Embolism/Embolus	26	26
Ischemia	25	25
No Code Available	22	22
Ventricular Fibrillation	21	21
Vascular System (Circulation), Impaired	19	19
Pain	18	18
Cardiogenic Shock	17	17
Renal Failure	17	17
Angina	14	14
Vasoconstriction	14	14
Cardiac Enzyme Elevation	13	13
Discomfort	11	11
Cardiac Perforation	11	11
High Blood Pressure/ Hypertension	9	9
Tachycardia	8	8
Hematuria	7	7
Great Vessel Perforation	7	7
Pseudoaneurysm	7	7
Hypersensitivity/Allergic reaction	7	7
Stroke/CVA	7	7
ST Segment Elevation	7	7
No Patient Involvement	7	7
Restenosis	7	7
Asystole	6	6
Heart Failure/Congestive Heart Failure	6	6
Unspecified Kidney or Urinary Problem	6	6

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Apr-12-2022
2	Boston Scientific Corporation	II	Dec-15-2021