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)
2019	2020	2021	2022	2023	2024
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	2601	2601
Material Twisted/Bent	721	721
Material Integrity Problem	491	491
Patient Device Interaction Problem	400	400
Optical Problem	371	371
Device Contamination with Body Fluid	354	354
Communication or Transmission Problem	235	235
Fluid/Blood Leak	234	234
Protective Measures Problem	204	204
Fracture	186	186
Incorrect, Inadequate or Imprecise Result or Readings	118	118
Electrical Shorting	117	117
Gas/Air Leak	101	101
Material Deformation	98	98
Temperature Problem	90	90
Coagulation in Device or Device Ingredient	81	81
Improper Flow or Infusion	75	75
Insufficient Cooling	72	72
Signal Artifact/Noise	68	68
Break	67	67
Mechanical Problem	62	62
Obstruction of Flow	61	61
Use of Device Problem	60	60
Contamination /Decontamination Problem	60	60
Leak/Splash	53	53
No Apparent Adverse Event	46	46
Display or Visual Feedback Problem	46	46
High impedance	44	44
Compatibility Problem	43	43
Overheating of Device	34	34
Failure to Sense	31	31
Impedance Problem	31	31
Infusion or Flow Problem	30	30
Appropriate Term/Code Not Available	26	26
Increase in Pressure	24	24
Device Contamination with Chemical or Other Material	20	20
Insufficient Information	19	19
Device Displays Incorrect Message	19	19
Off-Label Use	19	19
Output Problem	16	16
Device Handling Problem	15	15
Failure to Pump	15	15
Defective Device	14	14
Entrapment of Device	14	14
Excessive Cooling	13	13
Improper or Incorrect Procedure or Method	12	12
Material Frayed	12	12
Device Sensing Problem	12	12
Intermittent Communication Failure	12	12
Material Puncture/Hole	11	11

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	2603	2603
Cardiac Perforation	938	938
Nerve Damage	574	574
No Consequences Or Impact To Patient	396	396
Cardiac Tamponade	386	386
No Known Impact Or Consequence To Patient	380	380
Pericardial Effusion	312	312
Low Blood Pressure/ Hypotension	213	213
Stroke/CVA	210	210
Heart Block	87	87
Arrhythmia	77	77
Thrombosis/Thrombus	69	69
Pericarditis	67	67
Chest Pain	61	61
Hemorrhage/Bleeding	61	61
Fistula	58	58
Cardiac Arrest	54	54
Transient Ischemic Attack	51	51
Tachycardia	48	48
Non specific EKG/ECG Changes	45	45
Death	44	44
Insufficient Information	43	43
Stenosis	42	42
Dyspnea	40	40
Inflammation	39	39
Patient Problem/Medical Problem	38	38
Perforation of Esophagus	38	38
Atrial Fibrillation	37	37
Pseudoaneurysm	36	36
Atrial Flutter	35	35
Hematoma	33	33
Thrombus	31	31
Air Embolism	30	30
Paresis	28	28
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	27	27
Heart Failure/Congestive Heart Failure	26	26
Hemoptysis	26	26
Pulmonary Valve Stenosis	25	25
Embolism/Embolus	24	24
Perforation	24	24
Vascular Dissection	24	24
ST Segment Elevation	23	23
Pain	22	22
Embolism	21	21
Paralysis	19	19
Pleural Effusion	18	18
Ventricular Fibrillation	18	18
Bradycardia	17	17
Vomiting	17	17
Tissue Damage	17	17

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	EPIX THERAPEUTICS, INC	II	Mar-29-2021
6	Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)	III	Mar-28-2019
7	St. Jude Medical, Atrial Fibrillation Division, Inc.	II	Jan-25-2024