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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 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
Obstruction of Flow 2 2
Coagulation in Device or Device Ingredient 2 2
Power Problem 2 2
Unsealed Device Packaging 2 2
Positioning Problem 2 2
Signal Artifact/Noise 2 2
Packaging Problem 2 2
Device Contamination with Body Fluid 2 2
Difficult to Insert 1 1
Difficult to Advance 1 1
Image Display Error/Artifact 1 1
Fitting Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Unexpected Shutdown 1 1
No Apparent Adverse Event 1 1
Separation Problem 1 1
Connection Problem 1 1
Compatibility Problem 1 1
Arcing of Electrodes 1 1
Noise, Audible 1 1
Communication or Transmission Problem 1 1
Break 1 1
Difficult to Open or Remove Packaging Material 1 1
Electrical /Electronic Property Problem 1 1
Device Displays Incorrect Message 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
Hemolysis 9 9
Renal Failure 9 9
Tachycardia 9 9
Vasoconstriction 9 9
Bradycardia 8 8
Heart Block 8 8
Dyspnea 8 8
Chest Pain 7 7
Cardiac Perforation 7 7
Cardiac Arrest 6 6
Respiratory Insufficiency 4 4
Pericarditis 4 4
Air Embolism 3 3
Heart Failure/Congestive Heart Failure 3 3
Ischemia Stroke 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Electric Shock 3 3
Hematuria 3 3
Hemorrhage/Bleeding 3 3
Swelling/ Edema 3 3
Urinary Retention 3 3
Fever 3 3
Asystole 2 2
Pulmonary Edema 2 2
Renal Impairment 2 2
Vomiting 2 2
Pleural Effusion 2 2
Nerve Damage 2 2
Thrombosis/Thrombus 2 2
Ventricular Fibrillation 2 2
Intracranial Hemorrhage 2 2
Convulsion/Seizure 2 2
Transient Ischemic Attack 2 2
Cognitive Changes 2 2
Embolism/Embolus 2 2
Unspecified Respiratory Problem 2 2
Headache 2 2
Hematoma 2 2
Necrosis 2 2

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