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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)
2019 2020 2021 2022 2023 2024
39 42 50 20 19 12

MDR Year MDR Reports MDR Events
2019 475 475
2020 389 389
2021 401 401
2022 344 344
2023 319 319
2024 203 203

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 648 648
Material Integrity Problem 253 253
Patient Device Interaction Problem 183 183
Temperature Problem 157 157
Fluid/Blood Leak 133 133
Device Displays Incorrect Message 97 97
Improper Flow or Infusion 67 67
Leak/Splash 60 60
Communication or Transmission Problem 57 57
Defective Device 53 53
Signal Artifact/Noise 39 39
Positioning Problem 39 39
Poor Quality Image 35 35
Obstruction of Flow 33 33
Device Remains Activated 30 30
Fracture 29 29
Data Problem 28 28
Mechanics Altered 25 25
Device Contamination with Chemical or Other Material 24 24
Failure to Deliver Energy 23 23
Break 22 22
Impedance Problem 22 22
Noise, Audible 20 20
Detachment of Device or Device Component 19 19
Material Perforation 19 19
Power Conditioning Problem 18 18
Material Deformation 13 13
Tear, Rip or Hole in Device Packaging 12 12
Crack 12 12
Improper or Incorrect Procedure or Method 12 12
High impedance 12 12
Output Problem 12 12
Thermal Decomposition of Device 11 11
Insufficient Flow or Under Infusion 11 11
Mechanical Jam 11 11
Material Twisted/Bent 10 10
Insufficient Information 10 10
Overheating of Device 10 10
Activation, Positioning or Separation Problem 10 10
Pressure Problem 10 10
No Apparent Adverse Event 9 9
Material Protrusion/Extrusion 9 9
Failure to Power Up 8 8
Contamination 8 8
Connection Problem 8 8
Insufficient Cooling 8 8
Device Contamination with Body Fluid 8 8
Entrapment of Device 8 8
Display or Visual Feedback Problem 7 7
Failure to Sense 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 807 807
No Consequences Or Impact To Patient 353 353
Cardiac Perforation 239 239
Cardiac Tamponade 202 202
No Known Impact Or Consequence To Patient 105 105
Pericardial Effusion 98 98
Stroke/CVA 65 65
Low Blood Pressure/ Hypotension 49 49
Heart Block 47 47
Arrhythmia 35 35
Death 30 30
Fistula 29 29
Pseudoaneurysm 26 26
Cardiac Arrest 25 25
Hematoma 25 25
No Code Available 25 25
Nerve Damage 23 23
Chest Pain 23 23
Insufficient Information 19 19
Transient Ischemic Attack 19 19
Complete Heart Block 19 19
Thrombosis/Thrombus 17 17
Air Embolism 16 16
Hemorrhage/Bleeding 15 15
Vascular Dissection 15 15
Stenosis 14 14
Pericarditis 14 14
Paralysis 14 14
Perforation of Esophagus 12 12
Dyspnea 11 11
Atrial Fibrillation 10 10
Ventricular Fibrillation 10 10
Thrombosis 8 8
Tissue Damage 8 8
Vasoconstriction 7 7
Myocardial Infarction 6 6
Unspecified Infection 6 6
Pneumothorax 6 6
Bradycardia 6 6
Burn(s) 6 6
Cardiogenic Shock 5 5
Embolism/Embolus 5 5
Tachycardia 5 5
Thrombus 5 5
Injury 5 5
Pain 5 5
Headache 4 4
Sepsis 4 4
Ventricular Tachycardia 4 4
Partial thickness (Second Degree) Burn 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation III Jan-08-2019
2 Johnson & Johnson Surgical Vision, Inc. II Nov-02-2022
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