TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
10	5	12	10	13	18	25	16	23	13	15	20	9	12	18	7

Device Problems	MDRs with this Device Problem	Events in those MDRs
Entrapment of Device	2058	2058
Adverse Event Without Identified Device or Use Problem	1490	1490
Material Separation	630	630
Fracture	568	568
Device Damaged by Another Device	525	525
Detachment of Device or Device Component	482	482
Output Problem	404	404
Difficult to Remove	261	261
Detachment Of Device Component	207	207
Device Operates Differently Than Expected	207	207
No Display/Image	171	171
Failure to Advance	166	166
Break	166	166
Material Deformation	159	159
Intermittent Loss of Power	153	153
Material Integrity Problem	134	134
Mechanical Problem	121	121
Noise, Audible	106	106
Display or Visual Feedback Problem	103	103
Device Contamination with Chemical or Other Material	95	95
Unintended System Motion	95	95
Difficult to Advance	89	89
Fluid/Blood Leak	82	82
Defective Device	68	68
Unstable	65	65
Physical Resistance/Sticking	59	59
Leak/Splash	56	56
Kinked	55	55
Device Displays Incorrect Message	51	51
Aspiration Issue	44	44
Mechanical Jam	44	44
Gas/Air Leak	44	44
Material Split, Cut or Torn	38	38
Device Damaged Prior to Use	36	36
Insufficient Information	35	35
Positioning Problem	32	32
Stretched	30	30
Contamination	28	28
Sticking	27	27
Defective Component	24	24
Device-Device Incompatibility	24	24
Unsealed Device Packaging	21	21
Difficult to Insert	20	20
Torn Material	19	19
Suction Problem	18	18
Material Twisted/Bent	17	17
Unintended Movement	16	16
Physical Resistance	16	16
Unexpected Shutdown	15	15
Hole In Material	15	15

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	2637	2637
No Clinical Signs, Symptoms or Conditions	1717	1717
Perforation of Vessels	831	831
Foreign Body In Patient	675	675
Device Embedded In Tissue or Plaque	425	425
Vascular Dissection	362	362
Death	357	357
No Patient Involvement	291	291
No Known Impact Or Consequence To Patient	277	277
Low Blood Pressure/ Hypotension	185	185
Chest Pain	133	133
Perforation	130	130
Cardiac Arrest	118	118
No Code Available	110	110
Myocardial Infarction	107	107
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	98	98
Pericardial Effusion	78	78
Bradycardia	72	72
Cardiac Perforation	67	67
Insufficient Information	65	65
Hematoma	61	61
Thrombus	58	58
Intimal Dissection	58	58
Cardiac Tamponade	55	55
Obstruction/Occlusion	51	51
Ventricular Fibrillation	49	49
Vascular System (Circulation), Impaired	44	44
Hemorrhage/Bleeding	36	36
Non specific EKG/ECG Changes	33	33
Arrhythmia	25	25
ST Segment Elevation	25	25
Pain	22	22
Thrombosis/Thrombus	22	22
Ischemia	20	20
Thrombosis	18	18
Pseudoaneurysm	17	17
Tachycardia	16	16
Renal Failure	16	16
Cardiopulmonary Arrest	15	15
No Information	14	14
Embolism/Embolus	13	13
Vessel Or Plaque, Device Embedded In	13	13
Vasoconstriction	13	13
Cardiogenic Shock	12	12
Injury	11	11
Ventricular Tachycardia	11	11
Discomfort	10	10
Loss of consciousness	10	10
High Blood Pressure/ Hypertension	9	9
Cardiac Enzyme Elevation	9	9

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Apr-12-2022
2	Boston Scientific Corporation	II	Dec-15-2021
3	Boston Scientific Corporation	II	Dec-19-2019
4	Boston Scientific Corporation	II	Mar-03-2017
5	Boston Scientific Corporation	I	Nov-13-2015
6	Cardiovascular Systems Inc	II	Sep-11-2018
7	Cardiovascular Systems Inc	II	May-20-2017
8	Cardiovascular Systems, Inc.	I	Mar-20-2015
9	Cardiovascular Systems, Inc.	III	Feb-26-2014