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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
9 12 21 19 30 25 24 47 64 29 39 42 50 20 19 6

MDR Year MDR Reports MDR Events
2014 328 328
2015 273 273
2016 239 239
2017 403 403
2018 423 423
2019 475 475
2020 389 389
2021 401 401
2022 344 344
2023 319 319
2024 100 100

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1395 1395
Material Integrity Problem 255 255
Temperature Problem 189 189
Insufficient Information 181 181
Patient Device Interaction Problem 173 173
Fluid/Blood Leak 132 132
Device Displays Incorrect Message 132 132
Device Operates Differently Than Expected 104 104
Break 103 103
Improper Flow or Infusion 68 68
Leak/Splash 65 65
Communication or Transmission Problem 65 65
Kinked 54 54
Signal Artifact/Noise 54 54
Device Remains Activated 52 52
Defective Device 50 50
Bent 44 44
Positioning Problem 43 43
Impedance Problem 38 38
Noise, Audible 37 37
Device Contamination with Chemical or Other Material 37 37
Fracture 34 34
Poor Quality Image 34 34
Charred 33 33
Data Problem 29 29
Device Sensing Problem 28 28
Crack 27 27
Obstruction of Flow 26 26
Failure to Deliver Energy 25 25
Mechanics Altered 25 25
High impedance 24 24
Improper or Incorrect Procedure or Method 20 20
Material Perforation 20 20
Tear, Rip or Hole in Device Packaging 20 20
Detachment of Device or Device Component 19 19
Thermal Decomposition of Device 19 19
Electrical /Electronic Property Problem 18 18
Power Conditioning Problem 18 18
No Display/Image 16 16
Material Deformation 15 15
Insufficient Flow or Under Infusion 14 14
Difficult to Remove 14 14
Failure to Sense 14 14
Detachment Of Device Component 13 13
Material Protrusion/Extrusion 13 13
Material Twisted/Bent 13 13
Output Problem 12 12
Pressure Problem 12 12
Entrapment of Device 12 12
Failure to Power Up 12 12
Use of Device Problem 12 12
Material Separation 11 11
Connection Problem 11 11
Overheating of Device 11 11
Appropriate Term/Code Not Available 11 11
Mechanical Jam 10 10
Contamination 10 10
Activation, Positioning or Separation Problem 10 10
Display or Visual Feedback Problem 9 9
Mechanical Problem 8 8
Device Contamination with Body Fluid 8 8
Device Inoperable 8 8
Inadequate Storage 8 8
Scratched Material 8 8
Unsealed Device Packaging 7 7
Material Frayed 7 7
Material Discolored 6 6
Low impedance 6 6
Unintended Movement 6 6
Unexpected Shutdown 6 6
Unintended Electrical Shock 5 5
Material Split, Cut or Torn 5 5
No Apparent Adverse Event 5 5
Therapeutic or Diagnostic Output Failure 5 5
Output below Specifications 5 5
Sticking 5 5
Device-Device Incompatibility 5 5
Human-Device Interface Problem 5 5
Electrical Shorting 5 5
Hole In Material 5 5
No Device Output 5 5
Material Puncture/Hole 5 5
Degraded 4 4
Occlusion Within Device 4 4
Grounding Malfunction 4 4
Insufficient Heating 4 4
Insufficient Cooling 4 4
Device Packaging Compromised 4 4
Optical Problem 4 4
Device Contaminated During Manufacture or Shipping 4 4
Air/Gas in Device 4 4
Excessive Heating 3 3
Packaging Problem 3 3
Torn Material 3 3
Failure to Read Input Signal 3 3
Failure to Analyze Signal 3 3
Device Damaged Prior to Use 3 3
Cut In Material 3 3
Device Alarm System 3 3
Image Display Error/Artifact 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 766 766
No Clinical Signs, Symptoms or Conditions 731 731
Cardiac Perforation 477 477
Cardiac Tamponade 450 450
Pericardial Effusion 249 249
No Known Impact Or Consequence To Patient 235 235
Low Blood Pressure/ Hypotension 190 190
Stroke/CVA 118 118
Death 112 112
Fistula 70 70
No Code Available 69 69
Hematoma 56 56
Hemorrhage/Bleeding 47 47
Arrhythmia 47 47
Cardiac Arrest 46 46
Pseudoaneurysm 45 45
Complete Heart Block 45 45
Heart Block 42 42
Transient Ischemic Attack 41 41
Chest Pain 39 39
Nerve Damage 34 34
No Patient Involvement 34 34
Air Embolism 32 32
Thrombosis 31 31
Paralysis 28 28
Vascular Dissection 23 23
Stenosis 22 22
ST Segment Elevation 21 21
Dyspnea 21 21
Myocardial Infarction 19 19
Insufficient Information 19 19
Sepsis 18 18
Ventricular Fibrillation 18 18
Ventricular Tachycardia 18 18
Perforation of Esophagus 16 16
Atrial Fibrillation 15 15
Thrombosis/Thrombus 15 15
No Information 14 14
Pulmonary Embolism 14 14
Pleural Effusion 14 14
Injury 14 14
Laceration(s) of Esophagus 14 14
Perforation 13 13
Tachycardia 13 13
Heart Failure 13 13
Pain 13 13
Inflammation 13 13
Burn(s) 13 13
Pericarditis 13 13
Cardiogenic Shock 12 12
Aortic Dissection 12 12
Tissue Damage 11 11
Bradycardia 11 11
Pneumothorax 9 9
Thrombus 9 9
Blood Loss 9 9
Discomfort 8 8
Other (for use when an appropriate patient code cannot be identified) 8 8
Unspecified Infection 8 8
Dysphasia 7 7
Vasoconstriction 6 6
Perforation of Vessels 6 6
Respiratory Tract Infection 6 6
Atrial Perforation 6 6
Loss Of Pulse 6 6
Pulmonary Valve Stenosis 6 6
Bleeding 6 6
Partial thickness (Second Degree) Burn 6 6
Thromboembolism 6 6
Embolism 5 5
Pulmonary Edema 5 5
Pneumonia 5 5
Laceration(s) 5 5
Fever 5 5
Mitral Insufficiency 5 5
Electric Shock 5 5
Loss of consciousness 5 5
Visual Impairment 5 5
Weakness 4 4
Hematuria 4 4
Low Oxygen Saturation 4 4
Complaint, Ill-Defined 4 4
Numbness 4 4
Occlusion 4 4
High Blood Pressure/ Hypertension 4 4
Ischemia 4 4
Embolus 4 4
Fatigue 4 4
Non specific EKG/ECG Changes 4 4
Vaso-Vagal Response 4 4
Patient Problem/Medical Problem 4 4
Full thickness (Third Degree) Burn 4 4
Ischemia Stroke 4 4
Embolism/Embolus 4 4
Not Applicable 3 3
Heart Failure/Congestive Heart Failure 3 3
Asystole 3 3
Unspecified Heart Problem 3 3
Diminished Pulse Pressure 3 3
Unspecified Tissue Injury 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corp II Dec-22-2015
2 Boston Scientific Corp I Mar-02-2015
3 Boston Scientific Corporation III Jan-08-2019
4 Boston Scientific Corporation II Aug-28-2018
5 Boston Scientific Corporation II Jun-16-2014
6 Endologix Inc II Jan-11-2010
7 Johnson & Johnson Surgical Vision, Inc. II Nov-02-2022
8 St Jude Medical Inc II Feb-14-2012
9 St. Jude Medical II Nov-08-2013
10 St. Jude Medical II Nov-06-2013
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