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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 8

MDR Year MDR Reports MDR Events
2024 700 700

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 222 222
Entrapment of Device 126 126
Detachment of Device or Device Component 93 93
Material Twisted/Bent 60 60
Material Deformation 44 44
Off-Label Use 43 43
Material Integrity Problem 42 42
Positioning Failure 39 39
Fluid/Blood Leak 32 32
Improper Flow or Infusion 30 30
Device Contamination with Chemical or Other Material 23 23
Activation, Positioning or Separation Problem 22 22
Difficult to Flush 18 18
Defective Device 18 18
Air/Gas in Device 13 13
Difficult to Remove 12 12
Use of Device Problem 10 10
Device-Device Incompatibility 5 5
Leak/Splash 4 4
Thermal Decomposition of Device 4 4
Contamination 3 3
Coagulation in Device or Device Ingredient 2 2
Power Problem 2 2
Packaging Problem 2 2
Obstruction of Flow 2 2
Positioning Problem 2 2
Unsealed Device Packaging 2 2
Device Contamination with Body Fluid 2 2
Signal Artifact/Noise 2 2
Difficult to Insert 1 1
Difficult to Advance 1 1
Image Display Error/Artifact 1 1
Difficult to Open or Remove Packaging Material 1 1
Communication or Transmission Problem 1 1
Break 1 1
Tear, Rip or Hole in Device Packaging 1 1
Separation Problem 1 1
Unexpected Shutdown 1 1
No Apparent Adverse Event 1 1
Compatibility Problem 1 1
Fitting Problem 1 1
Connection Problem 1 1
Electrical /Electronic Property Problem 1 1
Device Displays Incorrect Message 1 1
Arcing of Electrodes 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 445 445
Pericardial Effusion 40 40
Low Blood Pressure/ Hypotension 36 36
Atrial Fibrillation 28 28
Syncope/Fainting 27 27
Cardiac Tamponade 26 26
Unspecified Tissue Injury 19 19
Arrhythmia 17 17
Atrial Flutter 15 15
Non specific EKG/ECG Changes 13 13
Stroke/CVA 10 10
Tachycardia 9 9
Renal Failure 9 9
Hemolysis 9 9
Vasoconstriction 9 9
Bradycardia 8 8
Dyspnea 8 8
Heart Block 8 8
Chest Pain 7 7
Cardiac Perforation 7 7
Cardiac Arrest 6 6
Respiratory Insufficiency 4 4
Pericarditis 4 4
Heart Failure/Congestive Heart Failure 3 3
Swelling/ Edema 3 3
Urinary Retention 3 3
Fever 3 3
Hemorrhage/Bleeding 3 3
Hematuria 3 3
Ischemia Stroke 3 3
Electric Shock 3 3
Air Embolism 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Hematoma 2 2
Cognitive Changes 2 2
Embolism/Embolus 2 2
Transient Ischemic Attack 2 2
Convulsion/Seizure 2 2
Intracranial Hemorrhage 2 2
Headache 2 2
Necrosis 2 2
Unspecified Respiratory Problem 2 2
Thrombosis/Thrombus 2 2
Ventricular Fibrillation 2 2
Vomiting 2 2
Pleural Effusion 2 2
Nerve Damage 2 2
High Blood Pressure/ Hypertension 2 2
Renal Impairment 2 2
Pulmonary Edema 2 2

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