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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device surgical cardiac ablation device, for treatment of atrial fibrillation
Definition Surgical cardiac ablation for the treatment of atrial fibrillation.
Product CodeOCM
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
1 5 7 2 5 0

MDR Year MDR Reports MDR Events
2021 6 6
2022 5 5
2023 3 3
2024 16 16
2025 10 10
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 35 35
Activation, Positioning or Separation Problem 1 1
Output Problem 1 1
Suction Failure 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Labelling, Instructions for Use or Training Problem 1 1
Explosion 1 1
Suction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Perforation 8 8
Stroke/CVA 5 5
No Clinical Signs, Symptoms or Conditions 5 5
Pericardial Effusion 3 3
Pulmonary Valve Stenosis 3 3
Cardiac Tamponade 2 2
Insufficient Information 2 2
Great Vessel Perforation 2 2
Hemorrhage/Bleeding 2 2
Ischemia Stroke 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Arrhythmia 1 1
Perforation 1 1
Pericarditis 1 1
Cardiac Arrest 1 1
Ventricular Fibrillation 1 1
Hernia 1 1
Paresis 1 1
Heart Failure/Congestive Heart Failure 1 1
Stenosis 1 1
Fistula 1 1

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