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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Definition For the treatment of atrial flutter.
Product CodeOAD
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
42 50 20 19 19 18

MDR Year MDR Reports MDR Events
2020 389 389
2021 402 403
2022 344 344
2023 319 322
2024 290 291
2025 173 173

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 484 485
Material Integrity Problem 254 254
Patient Device Interaction Problem 214 215
Fluid/Blood Leak 136 136
Temperature Problem 130 130
Device Displays Incorrect Message 96 96
Improper Flow or Infusion 56 56
Obstruction of Flow 52 52
Leak/Splash 50 50
Communication or Transmission Problem 50 50
Defective Device 45 45
Signal Artifact/Noise 41 41
Positioning Problem 35 35
Fracture 30 30
Poor Quality Image 26 26
Insufficient Cooling 25 25
Device Contamination with Chemical or Other Material 23 23
Impedance Problem 21 21
Break 21 22
Noise, Audible 18 18
Failure to Deliver Energy 18 18
Material Perforation 17 17
Insufficient Flow or Under Infusion 16 16
Detachment of Device or Device Component 16 16
Improper or Incorrect Procedure or Method 14 14
Data Problem 13 13
Mechanics Altered 13 13
Mechanical Jam 12 12
Tear, Rip or Hole in Device Packaging 12 12
Material Twisted/Bent 12 12
Activation, Positioning or Separation Problem 11 11
Connection Problem 11 11
Output Problem 11 11
High impedance 11 11
Pressure Problem 11 11
Material Deformation 11 11
Overheating of Device 10 10
Crack 10 10
Power Conditioning Problem 10 10
Thermal Decomposition of Device 10 10
Device Contamination with Body Fluid 10 10
Failure to Sense 9 9
Contamination 9 9
No Apparent Adverse Event 9 9
Material Protrusion/Extrusion 9 9
Insufficient Information 8 8
Entrapment of Device 8 8
Device Remains Activated 8 8
Display or Visual Feedback Problem 7 7
Incorrect, Inadequate or Imprecise Result or Readings 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 961 963
Cardiac Perforation 179 179
Cardiac Tamponade 168 169
No Consequences Or Impact To Patient 157 157
Pericardial Effusion 78 78
No Known Impact Or Consequence To Patient 64 64
Heart Block 62 63
Stroke/CVA 57 57
Low Blood Pressure/ Hypotension 37 37
Arrhythmia 33 33
Nerve Damage 25 25
Insufficient Information 21 21
Thrombosis/Thrombus 21 21
Fistula 21 21
Pseudoaneurysm 19 19
Cardiac Arrest 19 19
Chest Pain 18 18
Hematoma 18 18
Pericarditis 16 16
Air Embolism 15 15
Tachycardia 15 15
Transient Ischemic Attack 15 15
Stenosis 14 14
Vascular Dissection 14 14
Death 14 14
Perforation of Esophagus 12 13
Paralysis 12 12
Atrial Fibrillation 11 11
Dyspnea 10 10
Hemorrhage/Bleeding 9 9
Tissue Damage 7 7
No Code Available 7 7
Ventricular Fibrillation 7 7
Embolism/Embolus 7 7
Complete Heart Block 7 7
Bradycardia 6 6
Pulmonary Embolism 6 6
Myocardial Infarction 6 6
Thrombosis 5 5
Injury 5 5
Pain 5 5
Perforation 5 5
Vasoconstriction 5 5
Headache 5 5
Unspecified Tissue Injury 5 5
Cardiogenic Shock 4 4
Unspecified Infection 4 4
Burn(s) 4 4
Non specific EKG/ECG Changes 4 4
Thrombus 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Johnson & Johnson Surgical Vision, Inc. II Nov-02-2022
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