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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device percutaneous cardiac ablation catheter for treatment of atrial fibrillation with irreversible electroporation
Definition For the treatment of atrial fibrillation.
Product CodeQZI
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
0 0 0 0 1 2

MDR Year MDR Reports MDR Events
2024 118 118

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 48 48
Entrapment of Device 13 13
Material Integrity Problem 11 11
Device Contamination with Chemical or Other Material 9 9
Detachment of Device or Device Component 8 8
Positioning Failure 7 7
Activation, Positioning or Separation Problem 7 7
Material Deformation 6 6
Material Twisted/Bent 4 4
Improper Flow or Infusion 4 4
Air/Gas in Device 4 4
Defective Device 3 3
Difficult to Remove 2 2
Obstruction of Flow 2 2
Leak/Splash 2 2
Off-Label Use 1 1
Fluid/Blood Leak 1 1
Difficult to Flush 1 1
Device Displays Incorrect Message 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 64 64
Syncope/Fainting 13 13
Low Blood Pressure/ Hypotension 6 6
Bradycardia 4 4
Cardiac Tamponade 4 4
Pericardial Effusion 3 3
Unspecified Tissue Injury 3 3
Vomiting 2 2
Hemorrhage/Bleeding 2 2
Vasoconstriction 2 2
Electric Shock 2 2
Stroke/CVA 2 2
Arrhythmia 2 2
Atrial Fibrillation 2 2
Dyspnea 2 2
Non specific EKG/ECG Changes 2 2
Fever 2 2
Pleural Effusion 2 2
Pulmonary Edema 1 1
Renal Failure 1 1
Tachycardia 1 1
Transient Ischemic Attack 1 1
Urinary Retention 1 1
Unspecified Infection 1 1
Liver Damage/Dysfunction 1 1
Necrosis 1 1
Pain 1 1
Hemoptysis 1 1
Fatigue 1 1
Atrial Flutter 1 1
Chest Pain 1 1
Hematuria 1 1
Weight Changes 1 1
Dysuria 1 1
Ischemia Stroke 1 1
Embolism/Embolus 1 1
Heart Block 1 1
Heart Failure/Congestive Heart Failure 1 1
Pericarditis 1 1
Unspecified Respiratory Problem 1 1
Visual Disturbances 1 1
Intracranial Hemorrhage 1 1
Needle Stick/Puncture 1 1
Respiratory Failure 1 1
Shaking/Tremors 1 1
Pulmonary Embolism 1 1
Swelling/ Edema 1 1

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