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U.S. Department of Health and Human Services

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 CodeOAE
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 9

MDR Year MDR Reports MDR Events
2014 131 131
2015 274 274
2016 311 311
2017 387 387
2018 884 884
2019 908 908
2020 744 744
2021 914 914
2022 1162 1162
2023 1312 1312
2024 471 471

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3232 3232
Material Twisted/Bent 728 728
Material Integrity Problem 583 583
Optical Problem 365 365
Fluid/Blood Leak 345 345
Patient Device Interaction Problem 285 285
Device Contamination with Body Fluid 258 258
Communication or Transmission Problem 233 233
Insufficient Information 188 188
Fracture 174 174
Protective Measures Problem 170 170
Appropriate Term/Code Not Available 154 154
Material Deformation 135 135
Electrical Shorting 116 116
Kinked 100 100
Break 97 97
Gas/Air Leak 96 96
Device Displays Incorrect Message 82 82
Temperature Problem 79 79
Leak/Splash 77 77
Improper Flow or Infusion 70 70
Device Operates Differently Than Expected 70 70
Air Leak 59 59
Signal Artifact/Noise 54 54
Incorrect, Inadequate or Imprecise Result or Readings 54 54
Use of Device Problem 51 51
No Apparent Adverse Event 50 50
Obstruction of Flow 49 49
High impedance 48 48
Mechanical Problem 46 46
Display or Visual Feedback Problem 40 40
Insufficient Cooling 36 36
Compatibility Problem 34 34
Impedance Problem 32 32
Contamination /Decontamination Problem 27 27
Coagulation in Device or Device Ingredient 25 25
Infusion or Flow Problem 22 22
Device Contamination with Chemical or Other Material 21 21
Overheating of Device 20 20
Increase in Pressure 17 17
Output Problem 17 17
Off-Label Use 15 15
Material Rupture 14 14
Improper or Incorrect Procedure or Method 14 14
Failure to Sense 12 12
Material Puncture/Hole 12 12
Material Frayed 12 12
Intermittent Communication Failure 12 12
Positioning Problem 11 11
Failure to Deliver Energy 11 11
Difficult to Insert 11 11
Defective Device 11 11
Connection Problem 11 11
Device Sensing Problem 9 9
Entrapment of Device 9 9
Data Problem 9 9
Device Handling Problem 8 8
Contamination 7 7
No Display/Image 7 7
Delivered as Unsterile Product 7 7
Failure to Pump 7 7
Failure to Analyze Signal 7 7
Activation, Positioning or Separation Problem 7 7
Insufficient Flow or Under Infusion 7 7
Material Separation 6 6
Detachment of Device or Device Component 6 6
Difficult to Advance 6 6
Difficult To Position 6 6
Inflation Problem 5 5
Suction Problem 5 5
Deformation Due to Compressive Stress 5 5
Noise, Audible 5 5
Therapeutic or Diagnostic Output Failure 4 4
Unintended Electrical Shock 4 4
Failure to Advance 4 4
Defective Component 4 4
Device Inoperable 4 4
Image Display Error/Artifact 4 4
Flushing Problem 4 4
Deflation Problem 4 4
Thermal Decomposition of Device 4 4
Retraction Problem 4 4
Moisture Damage 4 4
Nonstandard Device 3 3
Difficult to Remove 3 3
Electrical /Electronic Property Problem 3 3
Failure to Deliver 3 3
Calibration Problem 3 3
Mechanical Jam 3 3
Mechanics Altered 3 3
Improper Device Output 3 3
Packaging Problem 3 3
Output below Specifications 2 2
Pressure Problem 2 2
Moisture or Humidity Problem 2 2
Device-Device Incompatibility 2 2
Aspiration Issue 2 2
Inaccurate Delivery 2 2
Tear, Rip or Hole in Device Packaging 2 2
Failure to Read Input Signal 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2039 2039
Cardiac Perforation 1177 1177
No Known Impact Or Consequence To Patient 900 900
Nerve Damage 757 758
No Consequences Or Impact To Patient 590 590
Pericardial Effusion 514 514
Cardiac Tamponade 414 414
Low Blood Pressure/ Hypotension 349 349
Stroke/CVA 235 235
Death 115 115
Fistula 99 99
ST Segment Elevation 87 87
Chest Pain 82 82
Arrhythmia 81 81
Heart Block 74 74
Hemorrhage/Bleeding 73 73
Cardiac Arrest 70 70
Dyspnea 67 67
Transient Ischemic Attack 64 64
Thrombosis/Thrombus 63 63
Air Embolism 62 62
No Code Available 60 60
Pericarditis 55 55
Tachycardia 54 54
Hematoma 51 51
Stenosis 50 50
Patient Problem/Medical Problem 49 49
Paresis 48 48
Inflammation 45 45
Thrombus 43 43
Pulmonary Valve Stenosis 39 39
Perforation 39 39
Bradycardia 38 38
Perforation of Esophagus 38 38
Pseudoaneurysm 37 37
Atrial Fibrillation 37 37
Non specific EKG/ECG Changes 36 36
Hemoptysis 36 37
Paralysis 36 36
Atrial Flutter 34 34
Insufficient Information 34 34
Vascular Dissection 31 31
Blood Loss 31 31
Embolism 29 29
Pain 29 29
Infarction, Cerebral 28 28
Fever 27 27
Pleural Effusion 25 25
Ventricular Fibrillation 25 25
Vomiting 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Heart Failure/Congestive Heart Failure 24 24
Nausea 22 22
Tissue Damage 22 22
Myocardial Infarction 21 21
Discomfort 19 19
Embolism/Embolus 18 18
Complete Heart Block 17 17
Hypoxia 16 17
Pneumothorax 15 15
No Information 15 15
Ischemia Stroke 14 14
Pulmonary Edema 14 14
Neurological Deficit/Dysfunction 13 13
Injury 12 12
High Blood Pressure/ Hypertension 12 12
No Patient Involvement 12 12
Laceration(s) of Esophagus 12 12
Vaso-Vagal Response 11 11
Unspecified Tissue Injury 11 11
Cardiovascular Insufficiency 10 10
Exit Block 10 10
Loss of consciousness 10 10
Bacterial Infection 10 10
Vasoconstriction 10 10
Muscle Weakness 10 10
Thrombosis 10 10
Pneumonia 9 9
Ventricular Tachycardia 9 9
Great Vessel Perforation 9 9
Dizziness 9 9
Pulmonary Embolism 9 9
Embolus 9 9
Fatigue 9 9
Intracranial Hemorrhage 8 8
Unspecified Infection 8 8
Peroneal Nerve Palsy 8 8
Sepsis 8 8
Headache 7 7
Abdominal Pain 7 7
Hematuria 7 7
Respiratory Failure 7 7
Aortic Dissection 7 7
Gastroesophageal Burn 7 7
Swelling/ Edema 7 7
Cough 6 6
Low Oxygen Saturation 6 6
Syncope/Fainting 6 6
Cardiopulmonary Arrest 6 6
Hemothorax 6 6

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
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