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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)
2018 2019 2020 2021 2022 2023
28 34 27 30 26 13

MDR Year MDR Reports MDR Events
2018 884 884
2019 908 908
2020 744 744
2021 913 913
2022 1163 1163
2023 346 346

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2208 2208
Material Twisted/Bent 647 647
Material Integrity Problem 464 464
Optical Problem 310 310
Fluid/Blood Leak 309 309
Communication or Transmission Problem 189 189
Device Contamination with Body Fluid 129 129
Material Deformation 125 125
Patient Device Interaction Problem 120 120
Electrical Shorting 109 109
Kinked 97 97
Break 90 90
Gas/Air Leak 90 90
Fracture 87 87
Protective Measures Problem 70 70
Appropriate Term/Code Not Available 61 61
Improper Flow or Infusion 55 55
Temperature Problem 39 39
High impedance 39 39
Leak/Splash 33 33
Signal Artifact/Noise 33 33
Use of Device Problem 32 32
No Apparent Adverse Event 32 32
Display or Visual Feedback Problem 29 29
Mechanical Problem 23 23
Impedance Problem 22 22
Obstruction of Flow 21 21
Compatibility Problem 16 16
Output Problem 16 16
Overheating of Device 15 15
Air Leak 12 12
Intermittent Communication Failure 12 12
Device Contamination with Chemical or Other Material 11 11
Material Frayed 11 11
Improper or Incorrect Procedure or Method 11 11
Device Displays Incorrect Message 11 11
Device Operates Differently Than Expected 9 9
Insufficient Information 9 9
Data Problem 8 8
Infusion or Flow Problem 8 8
Connection Problem 7 7
Failure to Analyze Signal 7 7
Delivered as Unsterile Product 7 7
Difficult to Insert 6 6
Failure to Deliver Energy 6 6
Entrapment of Device 6 6
Activation, Positioning or Separation Problem 6 6
Detachment of Device or Device Component 6 6
Device Sensing Problem 5 5
Deformation Due to Compressive Stress 5 5
Defective Device 5 5
Off-Label Use 5 5
Material Separation 5 5
Insufficient Flow or Under Infusion 4 4
No Display/Image 4 4
Contamination /Decontamination Problem 4 4
Device Handling Problem 4 4
Therapeutic or Diagnostic Output Failure 3 3
Unintended Electrical Shock 3 3
Mechanics Altered 3 3
Image Display Error/Artifact 3 3
Nonstandard Device 3 3
Thermal Decomposition of Device 3 3
Material Rupture 3 3
Calibration Problem 3 3
Inaccurate Delivery 2 2
Failure to Advance 2 2
Material Puncture/Hole 2 2
Low impedance 2 2
Defective Component 2 2
Contamination 2 2
Insufficient Cooling 2 2
Electrical /Electronic Property Problem 2 2
Partial Blockage 2 2
Energy Output Problem 2 2
No Device Output 2 2
Moisture Damage 2 2
Packaging Problem 2 2
Positioning Problem 2 2
Power Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Inadequate User Interface 1 1
Unexpected Shutdown 1 1
Excessive Heating 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Key or Button Unresponsive/not Working 1 1
Optical Obstruction 1 1
Poor Quality Image 1 1
Incorrect Measurement 1 1
Inflation Problem 1 1
Excess Flow or Over-Infusion 1 1
Material Fragmentation 1 1
False Alarm 1 1
Restricted Flow rate 1 1
Crack 1 1
Deflation Problem 1 1
Positioning Failure 1 1
Erratic or Intermittent Display 1 1
Material Perforation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1302 1302
Cardiac Perforation 804 804
No Known Impact Or Consequence To Patient 725 725
No Consequences Or Impact To Patient 542 542
Nerve Damage 491 492
Pericardial Effusion 265 265
Cardiac Tamponade 196 196
Low Blood Pressure/ Hypotension 163 163
Stroke/CVA 157 157
Death 66 66
Arrhythmia 56 56
Chest Pain 53 53
Patient Problem/Medical Problem 49 49
No Code Available 45 45
Heart Block 45 45
ST Segment Elevation 44 44
Transient Ischemic Attack 43 43
Fistula 43 43
Dyspnea 39 39
Thrombosis/Thrombus 39 39
Pericarditis 38 38
Air Embolism 37 37
Cardiac Arrest 36 36
Hemorrhage/Bleeding 36 36
Inflammation 36 36
Thrombus 34 34
Tachycardia 30 30
Paresis 30 30
Hematoma 28 28
Pseudoaneurysm 25 25
Insufficient Information 25 25
Perforation of Esophagus 24 24
Pulmonary Valve Stenosis 23 23
Embolism 23 23
Non specific EKG/ECG Changes 22 22
Blood Loss 22 22
Atrial Fibrillation 20 20
Pain 20 20
Vascular Dissection 20 20
Hemoptysis 19 19
Pleural Effusion 18 18
Atrial Flutter 18 18
Tissue Damage 18 18
Vomiting 17 17
Stenosis 17 17
Perforation 17 17
Bradycardia 16 16
Heart Failure/Congestive Heart Failure 16 16
Ventricular Fibrillation 15 15
Myocardial Infarction 14 14
Nausea 13 13
Paralysis 13 13
Infarction, Cerebral 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Embolism/Embolus 12 12
Complete Heart Block 12 12
Discomfort 11 11
Fever 11 11
Pulmonary Edema 11 11
Hypoxia 11 11
No Patient Involvement 10 10
Ischemia Stroke 10 10
Exit Block 9 9
Great Vessel Perforation 9 9
Bacterial Infection 9 9
Muscle Weakness 8 8
Vaso-Vagal Response 8 8
Unspecified Tissue Injury 8 8
Cardiovascular Insufficiency 7 7
No Information 7 7
Hematuria 7 7
Laceration(s) of Esophagus 7 7
Loss of consciousness 7 7
Dizziness 7 7
Vasoconstriction 7 7
Pneumonia 7 7
Pneumothorax 7 7
High Blood Pressure/ Hypertension 7 7
Intracranial Hemorrhage 6 6
Embolus 6 6
Sepsis 6 6
Thrombosis 5 5
Ventricular Tachycardia 5 5
Blurred Vision 5 5
Respiratory Failure 5 5
Aortic Dissection 5 5
Fatigue 5 5
Pulmonary Embolism 5 5
Neurological Deficit/Dysfunction 5 5
Gastroesophageal Burn 5 5
Retroperitoneal Hemorrhage 4 4
Swelling/ Edema 4 4
Syncope/Fainting 4 4
Hypersensitivity/Allergic reaction 4 4
Headache 4 4
Unspecified Infection 4 4
Cardiomyopathy 4 4
Obstruction/Occlusion 4 4
Vascular System (Circulation), Impaired 4 4
Thromboembolism 4 4

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
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