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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)
2021 2022 2023 2024 2025 2026
31 26 43 32 20 15

MDR Year MDR Reports MDR Events
2021 914 918
2022 1161 1163
2023 1311 1313
2024 2098 2103
2025 1432 1432
2026 441 441

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2495 2502
Patient Device Interaction Problem 853 854
Device Contamination with Body Fluid 566 566
Material Twisted/Bent 530 530
Optical Problem 418 418
Material Integrity Problem 404 405
Protective Measures Problem 345 345
Communication or Transmission Problem 289 289
Incorrect, Inadequate or Imprecise Result or Readings 286 286
Fracture 233 233
Coagulation in Device or Device Ingredient 201 201
Insufficient Cooling 146 147
Temperature Problem 129 130
Contamination /Decontamination Problem 128 128
Fluid/Blood Leak 124 124
Excessive Cooling 110 110
Obstruction of Flow 109 109
Mechanical Problem 105 105
Material Deformation 102 102
Improper Flow or Infusion 98 99
Signal Artifact/Noise 96 96
Use of Device Problem 92 92
Failure to Sense 78 78
Electrical Shorting 72 72
Display or Visual Feedback Problem 67 67
Compatibility Problem 66 66
Gas/Air Leak 64 64
Infusion or Flow Problem 57 57
Leak/Splash 57 57
Overheating of Device 54 54
No Apparent Adverse Event 50 50
High impedance 40 40
Device Sensing Problem 38 38
Insufficient Information 37 37
Off-Label Use 36 37
Impedance Problem 35 35
Increase in Pressure 35 35
Device Handling Problem 34 34
Material Separation 32 32
Appropriate Term/Code Not Available 29 29
Device Displays Incorrect Message 27 27
Device Contamination with Chemical or Other Material 24 25
Defective Device 22 22
Improper or Incorrect Procedure or Method 21 21
Connection Problem 20 20
Entrapment of Device 19 19
Failure to Pump 18 19
High Readings 15 15
Output Problem 14 14
Failure to Deliver Energy 14 14

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3954 3959
Cardiac Perforation 923 925
Cardiac Tamponade 631 632
Nerve Damage 503 503
Pericardial Effusion 314 314
Stroke/CVA 242 243
Low Blood Pressure/ Hypotension 222 222
Heart Block 169 169
Cardiac Arrest 103 103
Arrhythmia 98 98
Pericarditis 92 93
Thrombosis/Thrombus 92 92
Fistula 78 78
Tachycardia 77 77
Hemorrhage/Bleeding 77 78
Insufficient Information 70 70
Stenosis 69 69
Atrial Fibrillation 63 63
Chest Pain 62 62
Non specific EKG/ECG Changes 54 55
Perforation of Esophagus 47 47
Atrial Flutter 46 46
Transient Ischemic Attack 42 42
Heart Failure/Congestive Heart Failure 40 40
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 39 39
Air Embolism 38 38
Ventricular Fibrillation 35 35
Dyspnea 35 35
Hematoma 35 36
Pseudoaneurysm 34 35
Paralysis 32 32
Embolism/Embolus 32 32
Perforation 31 31
Bradycardia 29 29
Vascular Dissection 27 27
Inflammation 24 24
Paresis 24 24
Pleural Effusion 22 22
Unspecified Tissue Injury 22 22
Pain 22 22
Hemoptysis 21 21
Ischemia Stroke 19 19
Hypoxia 18 18
Vomiting 15 15
Pulmonary Edema 15 15
Fever 15 15
Unspecified Nervous System Problem 15 15
Foreign Body In Patient 14 14
Pulmonary Valve Stenosis 13 13
Nausea 13 13

Recalls
Manufacturer Recall Class Date Posted
1 Abbott I Oct-10-2025
2 Abbott II Jul-07-2022
3 Abbott II Apr-19-2022
4 Boston Scientific Corporation I Nov-12-2024
5 CardioFocus, Inc. II Mar-10-2025
6 EPIX THERAPEUTICS, INC II Mar-29-2021
7 St. Jude Medical, Atrial Fibrillation Division, Inc. II Jan-25-2024
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