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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 5

MDR Year MDR Reports MDR Events
2021 914 918
2022 1161 1163
2023 1311 1313
2024 2098 2103
2025 1432 1432
2026 73 73

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2402 2409
Patient Device Interaction Problem 765 766
Device Contamination with Body Fluid 551 551
Material Twisted/Bent 510 510
Optical Problem 399 399
Material Integrity Problem 389 390
Protective Measures Problem 325 325
Communication or Transmission Problem 269 269
Incorrect, Inadequate or Imprecise Result or Readings 266 266
Fracture 229 229
Coagulation in Device or Device Ingredient 198 198
Insufficient Cooling 136 137
Fluid/Blood Leak 123 123
Contamination /Decontamination Problem 120 120
Temperature Problem 119 120
Excessive Cooling 107 107
Mechanical Problem 103 103
Improper Flow or Infusion 98 99
Obstruction of Flow 98 98
Material Deformation 96 96
Signal Artifact/Noise 91 91
Use of Device Problem 91 91
Electrical Shorting 72 72
Failure to Sense 72 72
Display or Visual Feedback Problem 65 65
Compatibility Problem 63 63
Gas/Air Leak 62 62
Leak/Splash 57 57
Infusion or Flow Problem 55 55
Overheating of Device 53 53
No Apparent Adverse Event 49 49
High impedance 39 39
Insufficient Information 37 37
Impedance Problem 35 35
Increase in Pressure 33 33
Off-Label Use 32 33
Device Handling Problem 32 32
Device Sensing Problem 28 28
Appropriate Term/Code Not Available 28 28
Device Displays Incorrect Message 24 24
Device Contamination with Chemical or Other Material 24 25
Material Separation 22 22
Entrapment of Device 18 18
Improper or Incorrect Procedure or Method 18 18
Failure to Pump 18 19
Defective Device 17 17
Connection Problem 15 15
Failure to Deliver Energy 14 14
Output Problem 13 13
High Readings 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3769 3774
Cardiac Perforation 879 881
Cardiac Tamponade 584 585
Nerve Damage 495 495
Pericardial Effusion 299 299
Stroke/CVA 232 233
Low Blood Pressure/ Hypotension 212 212
Heart Block 155 155
Arrhythmia 91 91
Pericarditis 90 91
Cardiac Arrest 89 89
Thrombosis/Thrombus 89 89
Fistula 75 75
Tachycardia 74 74
Hemorrhage/Bleeding 73 74
Atrial Fibrillation 63 63
Stenosis 63 63
Chest Pain 62 62
Insufficient Information 60 60
Non specific EKG/ECG Changes 53 54
Atrial Flutter 46 46
Perforation of Esophagus 46 46
Transient Ischemic Attack 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Heart Failure/Congestive Heart Failure 38 38
Dyspnea 35 35
Air Embolism 34 34
Pseudoaneurysm 33 34
Hematoma 33 34
Ventricular Fibrillation 32 32
Embolism/Embolus 32 32
Perforation 30 30
Bradycardia 28 28
Paralysis 27 27
Vascular Dissection 26 26
Inflammation 24 24
Paresis 22 22
Pain 21 21
Pleural Effusion 21 21
Unspecified Tissue Injury 21 21
Hemoptysis 20 20
Ischemia Stroke 18 18
Hypoxia 16 16
Fever 15 15
Vomiting 14 14
Foreign Body In Patient 14 14
Pulmonary Edema 14 14
Unspecified Nervous System Problem 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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