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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 23

MDR Year MDR Reports MDR Events
2024 1430 1431
2025 4131 4131
2026 2360 2360

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2821 2822
Entrapment of Device 948 948
Material Deformation 726 726
Material Twisted/Bent 667 667
Off-Label Use 557 557
Patient Device Interaction Problem 371 371
Detachment of Device or Device Component 363 363
Device Contamination with Chemical or Other Material 314 314
Material Integrity Problem 309 309
Fluid/Blood Leak 233 233
Improper Flow or Infusion 219 219
Contamination 209 209
Nonstandard Device 165 165
Use of Device Problem 151 151
Break 148 148
Difficult to Flush 131 131
Positioning Failure 127 127
Difficult to Remove 126 126
Air/Gas in Device 116 116
Activation, Positioning or Separation Problem 110 110
Restricted Flow rate 92 92
Coagulation in Device or Device Ingredient 85 85
No Apparent Adverse Event 70 70
Defective Device 68 68
Thermal Decomposition of Device 59 59
Device-Device Incompatibility 59 59
Communication or Transmission Problem 53 53
Difficult to Advance 51 51
Unsealed Device Packaging 39 39
Tear, Rip or Hole in Device Packaging 38 38
Delivered as Unsterile Product 29 29
Mechanical Jam 29 29
Human-Device Interface Problem 28 28
Packaging Problem 27 27
Activation Failure 24 24
Positioning Problem 23 23
Signal Artifact/Noise 20 20
Physical Resistance/Sticking 19 19
Obstruction of Flow 19 19
Therapeutic or Diagnostic Output Failure 19 19
Clumping in Device or Device Ingredient 19 19
Difficult or Delayed Activation 18 18
Insufficient Information 17 17
Output Problem 16 16
Device Displays Incorrect Message 15 15
Deformation Due to Compressive Stress 15 15
Unintended Movement 14 14
Difficult to Open or Remove Packaging Material 13 13
Noise, Audible 13 13
Device Sensing Problem 13 13

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4201 4201
Pericardial Effusion 635 635
Low Blood Pressure/ Hypotension 589 589
Stroke/CVA 400 400
Cardiac Tamponade 367 367
Non specific EKG/ECG Changes 290 290
Atrial Fibrillation 201 202
Heart Block 198 198
Arrhythmia 197 197
Cardiac Arrest 187 187
Unspecified Tissue Injury 176 176
Tachycardia 176 176
Bradycardia 173 173
Syncope/Fainting 163 163
Cardiac Perforation 155 155
Chest Pain 125 125
Ventricular Fibrillation 119 119
Hemolysis 109 109
Hemorrhage/Bleeding 108 108
Ischemia Stroke 107 107
Vasoconstriction 98 98
Atrial Flutter 97 97
Dyspnea 91 91
Pericarditis 90 90
Transient Ischemic Attack 80 80
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 74 74
Asystole 72 72
Thrombosis/Thrombus 71 71
Nerve Damage 65 65
Heart Failure/Congestive Heart Failure 62 62
Air Embolism 59 59
Renal Failure 55 55
Hypoxia 52 52
Hematoma 50 50
Muscle Weakness 46 46
Hematuria 41 41
Dizziness 40 40
Insufficient Information 39 39
High Blood Pressure/ Hypertension 38 38
Visual Disturbances 38 38
Vasospasm 38 38
Perforation 37 37
Pain 34 34
Pleural Effusion 32 32
Cramp(s) /Muscle Spasm(s) 29 29
Myocardial Infarction 29 29
Numbness 29 29
Anemia 29 29
Blurred Vision 28 28
Embolism/Embolus 28 28

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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