TPLC - Total Product Life Cycle

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Device	catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Definition	For the treatment of atrial flutter.
Product Code	OAD
Device Class	3

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
9	12	21	19	30	25	24	47	64	29	39	42	50	20	19	12

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1416	1416
Material Integrity Problem	264	264
Temperature Problem	195	195
Patient Device Interaction Problem	183	183
Insufficient Information	181	181
Fluid/Blood Leak	144	144
Device Displays Incorrect Message	136	136
Break	105	105
Device Operates Differently Than Expected	104	104
Improper Flow or Infusion	71	71
Communication or Transmission Problem	70	70
Leak/Splash	65	65
Signal Artifact/Noise	62	62
Kinked	54	54
Defective Device	54	54
Device Remains Activated	53	53
Positioning Problem	46	46
Bent	44	44
Impedance Problem	38	38
Fracture	37	37
Device Contamination with Chemical or Other Material	37	37
Noise, Audible	37	37
Poor Quality Image	36	36
Obstruction of Flow	34	34
Charred	33	33
Data Problem	31	31
Device Sensing Problem	28	28
Crack	27	27
Failure to Deliver Energy	26	26
Mechanics Altered	25	25
High impedance	24	24
Detachment of Device or Device Component	22	22
Improper or Incorrect Procedure or Method	20	20
Tear, Rip or Hole in Device Packaging	20	20
Material Perforation	20	20
Thermal Decomposition of Device	19	19
Power Conditioning Problem	18	18
Electrical /Electronic Property Problem	18	18
Material Deformation	17	17
No Display/Image	16	16
Failure to Sense	16	16
Material Twisted/Bent	14	14
Material Protrusion/Extrusion	14	14
Difficult to Remove	14	14
Insufficient Flow or Under Infusion	14	14
Detachment Of Device Component	13	13
Overheating of Device	13	13
Pressure Problem	13	13
Output Problem	12	12
Failure to Power Up	12	12

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	807	807
No Consequences Or Impact To Patient	766	766
Cardiac Perforation	487	487
Cardiac Tamponade	453	453
Pericardial Effusion	251	251
No Known Impact Or Consequence To Patient	235	235
Low Blood Pressure/ Hypotension	192	192
Stroke/CVA	121	121
Death	112	112
Fistula	70	70
No Code Available	69	69
Hematoma	56	56
Arrhythmia	50	50
Heart Block	47	47
Hemorrhage/Bleeding	47	47
Cardiac Arrest	46	46
Complete Heart Block	45	45
Pseudoaneurysm	45	45
Transient Ischemic Attack	41	41
Chest Pain	40	40
Nerve Damage	35	35
No Patient Involvement	34	34
Air Embolism	32	32
Thrombosis	31	31
Paralysis	28	28
Vascular Dissection	23	23
Stenosis	22	22
Dyspnea	22	22
ST Segment Elevation	21	21
Myocardial Infarction	19	19
Insufficient Information	19	19
Ventricular Fibrillation	18	18
Ventricular Tachycardia	18	18
Sepsis	18	18
Thrombosis/Thrombus	17	17
Perforation of Esophagus	16	16
Atrial Fibrillation	16	16
Pericarditis	14	14
Pulmonary Embolism	14	14
Injury	14	14
Laceration(s) of Esophagus	14	14
Pleural Effusion	14	14
No Information	14	14
Burn(s)	13	13
Heart Failure	13	13
Perforation	13	13
Inflammation	13	13
Tachycardia	13	13
Pain	13	13
Cardiogenic Shock	12	12

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corp	II	Dec-22-2015
2	Boston Scientific Corp	I	Mar-02-2015
3	Boston Scientific Corporation	III	Jan-08-2019
4	Boston Scientific Corporation	II	Aug-28-2018
5	Boston Scientific Corporation	II	Jun-16-2014
6	Endologix Inc	II	Jan-11-2010
7	Johnson & Johnson Surgical Vision, Inc.	II	Nov-02-2022
8	St Jude Medical Inc	II	Feb-14-2012
9	St. Jude Medical	II	Nov-08-2013
10	St. Jude Medical	II	Nov-06-2013