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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 627 627

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 3288 3288
Material Twisted/Bent 734 734
Material Integrity Problem 589 589
Optical Problem 372 372
Fluid/Blood Leak 346 346
Patient Device Interaction Problem 307 307
Device Contamination with Body Fluid 272 272
Communication or Transmission Problem 238 238
Insufficient Information 188 188
Fracture 176 176
Protective Measures Problem 174 174
Appropriate Term/Code Not Available 155 155
Material Deformation 136 136
Electrical Shorting 117 117
Kinked 100 100
Break 97 97
Gas/Air Leak 96 96
Temperature Problem 83 83
Device Displays Incorrect Message 82 82
Leak/Splash 79 79
Improper Flow or Infusion 72 72
Device Operates Differently Than Expected 70 70
Incorrect, Inadequate or Imprecise Result or Readings 64 64
Air Leak 59 59
Signal Artifact/Noise 56 56
Use of Device Problem 51 51
No Apparent Adverse Event 51 51
Obstruction of Flow 50 50
High impedance 48 48
Mechanical Problem 47 47
Display or Visual Feedback Problem 41 41
Insufficient Cooling 40 40
Compatibility Problem 35 35
Impedance Problem 34 34
Contamination /Decontamination Problem 31 31
Coagulation in Device or Device Ingredient 28 28
Device Contamination with Chemical or Other Material 23 23
Infusion or Flow Problem 22 22
Overheating of Device 22 22
Increase in Pressure 18 18
Output Problem 17 17
Off-Label Use 15 15
Material Rupture 14 14
Failure to Sense 14 14
Improper or Incorrect Procedure or Method 14 14
Defective Device 12 12
Connection Problem 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
Entrapment of Device 11 11
Difficult to Insert 11 11
Device Sensing Problem 11 11
Data Problem 9 9
Device Handling Problem 9 9
Failure to Pump 8 8
No Display/Image 7 7
Delivered as Unsterile Product 7 7
Contamination 7 7
Activation, Positioning or Separation Problem 7 7
Insufficient Flow or Under Infusion 7 7
Failure to Analyze Signal 7 7
Detachment of Device or Device Component 6 6
Difficult to Advance 6 6
Difficult To Position 6 6
Material Separation 6 6
Thermal Decomposition of Device 5 5
Flushing Problem 5 5
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
Defective Component 4 4
Failure to Advance 4 4
Device Inoperable 4 4
Mechanics Altered 4 4
Image Display Error/Artifact 4 4
Deflation Problem 4 4
Retraction Problem 4 4
Moisture Damage 4 4
Nonstandard Device 3 3
Difficult to Remove 3 3
Partial Blockage 3 3
Electrical /Electronic Property Problem 3 3
Mechanical Jam 3 3
Improper Device Output 3 3
Failure to Deliver 3 3
Calibration Problem 3 3
Packaging Problem 3 3
Output below Specifications 2 2
Pressure Problem 2 2
Unintended Deflation 2 2
Low impedance 2 2
High Readings 2 2
Component Missing 2 2
Inaccurate Delivery 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2117 2117
Cardiac Perforation 1196 1196
No Known Impact Or Consequence To Patient 900 900
Nerve Damage 774 775
No Consequences Or Impact To Patient 590 590
Pericardial Effusion 516 516
Cardiac Tamponade 435 435
Low Blood Pressure/ Hypotension 355 355
Stroke/CVA 239 239
Death 115 115
Fistula 100 100
ST Segment Elevation 87 87
Arrhythmia 84 84
Chest Pain 82 82
Heart Block 76 76
Hemorrhage/Bleeding 75 75
Cardiac Arrest 70 70
Dyspnea 67 67
Thrombosis/Thrombus 65 65
Transient Ischemic Attack 64 64
Air Embolism 62 62
No Code Available 60 60
Pericarditis 55 55
Tachycardia 54 54
Stenosis 51 51
Hematoma 51 51
Paresis 50 50
Patient Problem/Medical Problem 49 49
Inflammation 45 45
Thrombus 43 43
Pulmonary Valve Stenosis 41 41
Perforation 39 39
Bradycardia 39 39
Perforation of Esophagus 39 39
Atrial Fibrillation 38 38
Non specific EKG/ECG Changes 38 38
Pseudoaneurysm 37 37
Insufficient Information 36 36
Hemoptysis 36 37
Paralysis 36 36
Atrial Flutter 34 34
Blood Loss 31 31
Vascular Dissection 31 31
Embolism 29 29
Pain 29 29
Fever 28 28
Infarction, Cerebral 28 28
Vomiting 27 27
Ventricular Fibrillation 26 26
Pleural Effusion 26 26
Nausea 25 25
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 24 24
Heart Failure/Congestive Heart Failure 24 24
Myocardial Infarction 22 22
Tissue Damage 22 22
Embolism/Embolus 20 20
Discomfort 19 19
Hypoxia 19 20
Complete Heart Block 17 17
No Information 15 15
Pneumothorax 15 15
Pulmonary Edema 15 15
Ischemia Stroke 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
Unspecified Tissue Injury 12 12
Vaso-Vagal Response 11 11
Bacterial Infection 11 11
Pulmonary Embolism 10 10
Dizziness 10 10
Vasoconstriction 10 10
Pneumonia 10 10
Muscle Weakness 10 10
Thrombosis 10 10
Exit Block 10 10
Loss of consciousness 10 10
Cardiovascular Insufficiency 10 10
Ventricular Tachycardia 9 9
Great Vessel Perforation 9 9
Embolus 9 9
Fatigue 9 9
Intracranial Hemorrhage 8 8
Abdominal Pain 8 8
Sepsis 8 8
Unspecified Infection 8 8
Peroneal Nerve Palsy 8 8
Respiratory Failure 7 7
Aortic Dissection 7 7
Hematuria 7 7
Syncope/Fainting 7 7
Swelling/ Edema 7 7
Gastroesophageal Burn 7 7
Headache 7 7
Hemothorax 6 6
Cardiopulmonary Arrest 6 6
Blurred Vision 6 6
Ulcer 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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