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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 4

MDR Year MDR Reports MDR Events
2024 217 217

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 74 74
Entrapment of Device 34 34
Detachment of Device or Device Component 26 26
Material Integrity Problem 19 19
Device Contamination with Chemical or Other Material 13 13
Material Deformation 12 12
Positioning Failure 11 11
Improper Flow or Infusion 10 10
Activation, Positioning or Separation Problem 9 9
Air/Gas in Device 7 7
Off-Label Use 7 7
Material Twisted/Bent 6 6
Defective Device 5 5
Leak/Splash 3 3
Difficult to Remove 3 3
Fluid/Blood Leak 3 3
Difficult to Flush 2 2
Use of Device Problem 2 2
Obstruction of Flow 2 2
Device Displays Incorrect Message 1 1
Compatibility Problem 1 1
Difficult to Advance 1 1
Device Contamination with Body Fluid 1 1
Coagulation in Device or Device Ingredient 1 1
Positioning Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 129 129
Syncope/Fainting 20 20
Cardiac Tamponade 9 9
Low Blood Pressure/ Hypotension 8 8
Unspecified Tissue Injury 6 6
Bradycardia 5 5
Non specific EKG/ECG Changes 4 4
Heart Block 4 4
Pericardial Effusion 4 4
Arrhythmia 3 3
Atrial Fibrillation 3 3
Atrial Flutter 3 3
Stroke/CVA 3 3
Fever 3 3
Hemolysis 3 3
Renal Failure 3 3
Necrosis 2 2
Pleural Effusion 2 2
Vasoconstriction 2 2
Hemorrhage/Bleeding 2 2
Headache 2 2
Chest Pain 2 2
Dyspnea 2 2
Vomiting 2 2
Electric Shock 2 2
Hematuria 2 2
Embolism/Embolus 2 2
Weight Changes 1 1
Dysuria 1 1
Pulmonary Embolism 1 1
Presyncope 1 1
Heart Failure/Congestive Heart Failure 1 1
Pericarditis 1 1
Respiratory Insufficiency 1 1
Unspecified Respiratory Problem 1 1
Unspecified Kidney or Urinary Problem 1 1
Swelling/ Edema 1 1
Ischemia Stroke 1 1
Fall 1 1
Fatigue 1 1
Hematoma 1 1
Head Injury 1 1
Intracranial Hemorrhage 1 1
Hemoptysis 1 1
Loss of Vision 1 1
Visual Disturbances 1 1
Pulmonary Edema 1 1
Cardiogenic Shock 1 1
Needle Stick/Puncture 1 1
Respiratory Failure 1 1
Cardiac Perforation 1 1
Shaking/Tremors 1 1
Cognitive Changes 1 1
Pain 1 1
Unspecified Infection 1 1
Liver Damage/Dysfunction 1 1
Tachycardia 1 1
Transient Ischemic Attack 1 1
Urinary Retention 1 1

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