Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 11

MDR Year MDR Reports MDR Events
2024 805 805

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 253 253
Entrapment of Device 154 154
Detachment of Device or Device Component 100 100
Material Twisted/Bent 71 71
Material Deformation 53 53
Off-Label Use 52 52
Material Integrity Problem 48 48
Positioning Failure 42 42
Improper Flow or Infusion 36 36
Fluid/Blood Leak 35 35
Activation, Positioning or Separation Problem 26 26
Device Contamination with Chemical or Other Material 25 25
Difficult to Flush 20 20
Defective Device 19 19
Use of Device Problem 16 16
Difficult to Remove 15 15
Air/Gas in Device 12 12
Device-Device Incompatibility 5 5
Thermal Decomposition of Device 4 4
Leak/Splash 3 3
Coagulation in Device or Device Ingredient 3 3
Break 3 3
Unsealed Device Packaging 3 3
Positioning Problem 3 3
Contamination 3 3
Power Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Packaging Problem 2 2
Obstruction of Flow 2 2
Signal Artifact/Noise 2 2
Difficult to Insert 1 1
Insufficient Information 1 1
Unintended Movement 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
Device Contamination with Body Fluid 1 1
Separation Problem 1 1
Unexpected Shutdown 1 1
Device Contaminated During Manufacture or Shipping 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 509 509
Pericardial Effusion 48 48
Low Blood Pressure/ Hypotension 42 42
Cardiac Tamponade 30 30
Atrial Fibrillation 29 29
Syncope/Fainting 28 28
Unspecified Tissue Injury 24 24
Arrhythmia 18 18
Atrial Flutter 17 17
Non specific EKG/ECG Changes 14 14
Tachycardia 12 12
Stroke/CVA 12 12
Dyspnea 11 11
Cardiac Perforation 11 11
Renal Failure 9 9
Bradycardia 9 9
Chest Pain 9 9
Vasoconstriction 9 9
Hemolysis 9 9
Heart Block 8 8
Cardiac Arrest 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Ischemia Stroke 5 5
Respiratory Insufficiency 4 4
Hemorrhage/Bleeding 4 4
Pericarditis 4 4
Thrombosis/Thrombus 4 4
Air Embolism 3 3
Hematuria 3 3
Heart Failure/Congestive Heart Failure 3 3
Swelling/ Edema 3 3
Urinary Retention 3 3
Pleural Effusion 3 3
Transient Ischemic Attack 3 3
Nerve Damage 3 3
Fever 3 3
Hypoxia 3 3
Ventricular Fibrillation 3 3
Visual Disturbances 3 3
Electric Shock 3 3
Pulmonary Edema 2 2
Asystole 2 2
High Blood Pressure/ Hypertension 2 2
Unspecified Kidney or Urinary Problem 2 2
Renal Impairment 2 2
Vomiting 2 2
Pneumothorax 2 2
Paralysis 2 2
Intracranial Hemorrhage 2 2
Myocardial Infarction 2 2

-
-