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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)
2021 2022 2023 2024 2025 2026
0 0 1 16 40 10

MDR Year MDR Reports MDR Events
2024 1430 1431
2025 4131 4131
2026 787 787

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2110 2111
Entrapment of Device 846 846
Material Deformation 599 599
Material Twisted/Bent 582 582
Off-Label Use 489 489
Detachment of Device or Device Component 331 331
Material Integrity Problem 303 303
Patient Device Interaction Problem 276 276
Device Contamination with Chemical or Other Material 264 264
Improper Flow or Infusion 219 219
Fluid/Blood Leak 191 191
Contamination 158 158
Positioning Failure 126 126
Difficult to Flush 121 121
Use of Device Problem 115 115
Break 112 112
Air/Gas in Device 108 108
Difficult to Remove 107 107
Activation, Positioning or Separation Problem 100 100
Nonstandard Device 94 94
Coagulation in Device or Device Ingredient 84 84
Defective Device 64 64
Restricted Flow rate 53 53
Device-Device Incompatibility 48 48
Thermal Decomposition of Device 47 47
No Apparent Adverse Event 46 46
Tear, Rip or Hole in Device Packaging 38 38
Unsealed Device Packaging 35 35
Difficult to Advance 35 35
Packaging Problem 23 23
Mechanical Jam 22 22
Delivered as Unsterile Product 21 21
Communication or Transmission Problem 19 19
Positioning Problem 18 18
Insufficient Information 17 17
Clumping in Device or Device Ingredient 16 16
Activation Failure 15 15
Human-Device Interface Problem 15 15
Device Displays Incorrect Message 15 15
Obstruction of Flow 14 14
Physical Resistance/Sticking 13 13
Deformation Due to Compressive Stress 13 13
Unintended Movement 13 13
High Readings 12 12
Signal Artifact/Noise 12 12
Output Problem 12 12
Device Contaminated During Manufacture or Shipping 11 11
Connection Problem 11 11
Therapeutic or Diagnostic Output Failure 10 10
Device Sensing Problem 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3496 3496
Pericardial Effusion 494 494
Low Blood Pressure/ Hypotension 462 462
Stroke/CVA 316 316
Cardiac Tamponade 270 270
Non specific EKG/ECG Changes 232 232
Atrial Fibrillation 164 165
Arrhythmia 163 163
Unspecified Tissue Injury 149 149
Cardiac Arrest 147 147
Tachycardia 134 134
Heart Block 132 132
Cardiac Perforation 115 115
Bradycardia 94 94
Chest Pain 92 92
Ventricular Fibrillation 90 90
Vasoconstriction 89 89
Hemorrhage/Bleeding 87 87
Syncope/Fainting 81 81
Ischemia Stroke 80 80
Atrial Flutter 78 78
Hemolysis 76 76
Dyspnea 71 71
Pericarditis 60 60
Thrombosis/Thrombus 57 57
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 56 56
Transient Ischemic Attack 54 54
Heart Failure/Congestive Heart Failure 51 51
Nerve Damage 48 48
Renal Failure 45 45
Asystole 45 45
Air Embolism 44 44
Muscle Weakness 35 35
Hypoxia 34 34
Hematoma 33 33
Dizziness 32 32
Insufficient Information 31 31
Hematuria 30 30
Perforation 30 30
Pain 27 27
Visual Disturbances 27 27
High Blood Pressure/ Hypertension 27 27
Cramp(s) /Muscle Spasm(s) 27 27
Embolism/Embolus 24 24
Myocardial Infarction 24 24
Urinary Retention 24 24
Speech Disorder 23 23
Blurred Vision 22 22
Numbness 22 22
Paralysis 21 21

Recalls
Manufacturer Recall Class Date Posted
1 Biosense Webster, Inc. I Feb-28-2025
2 Boston Scientific Corporation II Aug-08-2025
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