TPLC - Total Product Life Cycle

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

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
1	1	14	10	10	15	15	19	15	28	34	27	31	26	43	22

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	3459	3459
Material Twisted/Bent	800	800
Material Integrity Problem	619	619
Patient Device Interaction Problem	400	400
Device Contamination with Body Fluid	389	389
Optical Problem	384	384
Fluid/Blood Leak	352	352
Communication or Transmission Problem	259	259
Protective Measures Problem	205	205
Insufficient Information	192	192
Fracture	188	188
Appropriate Term/Code Not Available	158	158
Material Deformation	152	152
Incorrect, Inadequate or Imprecise Result or Readings	119	119
Electrical Shorting	117	117
Gas/Air Leak	117	117
Temperature Problem	103	103
Kinked	100	100
Break	98	98
Device Displays Incorrect Message	83	83
Coagulation in Device or Device Ingredient	81	81
Leak/Splash	79	79
Improper Flow or Infusion	77	77
Signal Artifact/Noise	72	72
Insufficient Cooling	72	72
Device Operates Differently Than Expected	70	70
Use of Device Problem	67	67
Obstruction of Flow	64	64
Mechanical Problem	63	63
Contamination /Decontamination Problem	60	60
Air Leak	59	59
High impedance	51	51
No Apparent Adverse Event	51	51
Display or Visual Feedback Problem	48	48
Compatibility Problem	43	43
Impedance Problem	36	36
Overheating of Device	35	35
Failure to Sense	34	34
Infusion or Flow Problem	32	32
Device Contamination with Chemical or Other Material	24	24
Increase in Pressure	24	24
Off-Label Use	20	20
Improper or Incorrect Procedure or Method	19	19
Output Problem	17	17
Defective Device	17	17
Failure to Pump	15	15
Device Handling Problem	15	15
Entrapment of Device	14	14
Material Rupture	14	14
Connection Problem	13	13

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2603	2603
Cardiac Perforation	1253	1253
No Known Impact Or Consequence To Patient	900	900
Nerve Damage	809	810
No Consequences Or Impact To Patient	590	590
Pericardial Effusion	537	537
Cardiac Tamponade	497	497
Low Blood Pressure/ Hypotension	379	379
Stroke/CVA	255	255
Death	115	115
Fistula	109	109
Arrhythmia	94	94
ST Segment Elevation	87	87
Heart Block	87	87
Chest Pain	87	87
Hemorrhage/Bleeding	82	82
Cardiac Arrest	76	76
Dyspnea	70	70
Thrombosis/Thrombus	69	69
Transient Ischemic Attack	69	69
Pericarditis	67	67
Air Embolism	63	63
No Code Available	60	60
Stenosis	59	59
Tachycardia	57	57
Hematoma	56	56
Paresis	52	52
Patient Problem/Medical Problem	49	49
Inflammation	49	49
Non specific EKG/ECG Changes	46	46
Atrial Fibrillation	43	43
Thrombus	43	43
Insufficient Information	43	43
Pulmonary Valve Stenosis	42	42
Pseudoaneurysm	41	41
Perforation	41	41
Bradycardia	39	39
Perforation of Esophagus	39	39
Hemoptysis	38	39
Atrial Flutter	38	38
Paralysis	37	37
Vascular Dissection	32	32
Blood Loss	31	31
Fever	29	29
Embolism	29	29
Pain	29	29
Infarction, Cerebral	28	28
Vomiting	28	28
Ventricular Fibrillation	27	27
Pleural Effusion	27	27

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott	II	Jul-07-2022
2	Abbott	II	Apr-19-2022
3	Abbott	II	Jul-10-2020
4	Abbott Laboratories Inc. (St Jude Medical)	II	Apr-09-2020
5	Biosense Webster, Inc.	II	May-28-2015
6	Biosense Webster, Inc.	II	Feb-07-2012
7	EPIX THERAPEUTICS, INC	II	Mar-29-2021
8	Medtronic Inc. Cardiac Rhythm Disease Management	II	Nov-02-2011
9	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	III	Mar-28-2019
10	St Jude Medical	II	Mar-17-2015
11	St. Jude Medical, Atrial Fibrillation Division, Inc.	II	Jan-25-2024