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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cardiac ablation percutaneous catheter
Definition This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].
Product CodeLPB
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
30 33 39 25 22 6

MDR Year MDR Reports MDR Events
2019 1124 1124
2020 1182 1182
2021 1241 1241
2022 1336 1336
2023 1500 1500
2024 445 445

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 2769 2769
Adverse Event Without Identified Device or Use Problem 1701 1701
Material Puncture/Hole 589 589
High Readings 303 303
Contamination /Decontamination Problem 289 289
Incorrect, Inadequate or Imprecise Result or Readings 263 263
Failure to Sense 174 174
Device Contamination with Body Fluid 152 152
Signal Artifact/Noise 140 140
Coagulation in Device or Device Ingredient 134 134
Positioning Problem 81 81
Communication or Transmission Problem 77 77
Temperature Problem 75 75
Electrical Shorting 70 70
Insufficient Cooling 66 66
Obstruction of Flow 57 57
Protective Measures Problem 53 53
Break 52 52
Entrapment of Device 51 51
Tear, Rip or Hole in Device Packaging 51 51
Material Split, Cut or Torn 51 51
Display or Visual Feedback Problem 50 50
Material Twisted/Bent 43 43
Appropriate Term/Code Not Available 40 40
Device Sensing Problem 40 40
Material Integrity Problem 39 39
Crack 39 39
Sharp Edges 39 39
Detachment of Device or Device Component 36 36
Material Protrusion/Extrusion 33 33
Mechanical Jam 30 30
Defective Device 28 28
Device Remains Activated 28 28
Material Separation 26 26
Device Contamination with Chemical or Other Material 26 26
Delivered as Unsterile Product 25 25
Erratic or Intermittent Display 25 25
Image Orientation Incorrect 23 23
Expiration Date Error 21 21
Device Displays Incorrect Message 20 20
Complete Blockage 20 20
No Display/Image 18 18
Insufficient Information 18 18
Impedance Problem 17 17
Partial Blockage 17 17
High impedance 15 15
Separation Problem 15 15
Packaging Problem 14 14
Material Deformation 13 13
Material Opacification 13 13
Contamination 13 13
Infusion or Flow Problem 12 12
Material Perforation 12 12
Noise, Audible 12 12
Manufacturing, Packaging or Shipping Problem 11 11
Output Problem 11 11
Failure to Deliver Energy 11 11
Unable to Obtain Readings 11 11
Fluid/Blood Leak 10 10
Air/Gas in Device 10 10
Device-Device Incompatibility 9 9
Fail-Safe Did Not Operate 8 8
Therapeutic or Diagnostic Output Failure 7 7
Fracture 7 7
Decreased Pump Speed 7 7
Overheating of Device 7 7
Pacing Problem 7 7
Leak/Splash 7 7
Mechanical Problem 7 7
Product Quality Problem 6 6
Device Alarm System 6 6
No Apparent Adverse Event 6 6
Improper Flow or Infusion 6 6
Improper or Incorrect Procedure or Method 6 6
Low impedance 5 5
Defective Component 5 5
Off-Label Use 5 5
Excessive Heating 5 5
Failure to Zero 4 4
Application Program Problem 4 4
Connection Problem 4 4
Activation, Positioning or Separation Problem 4 4
Activation Failure 4 4
Thermal Decomposition of Device 4 4
Electrical /Electronic Property Problem 4 4
Failure to Transmit Record 4 4
Difficult to Remove 4 4
Failure to Analyze Signal 4 4
Failure to Unfold or Unwrap 4 4
Use of Device Problem 3 3
Device Emits Odor 3 3
Unsealed Device Packaging 3 3
Peeled/Delaminated 3 3
Energy Output Problem 3 3
Backflow 3 3
Mechanics Altered 3 3
Data Problem 2 2
Device Handling Problem 2 2
No Pacing 2 2
Output below Specifications 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Tamponade 2641 2641
No Clinical Signs, Symptoms or Conditions 1656 1656
No Consequences Or Impact To Patient 741 741
No Code Available 343 343
Heart Block 286 286
Stroke/CVA 284 284
Cardiac Arrest 231 231
Fistula 163 163
Cardiac Perforation 126 126
Pericardial Effusion 112 112
Paralysis 98 98
Death 85 85
Arrhythmia 78 78
Stenosis 60 60
Thrombosis/Thrombus 60 60
Ischemic Heart Disease 59 59
No Known Impact Or Consequence To Patient 57 57
Ventricular Fibrillation 49 49
Transient Ischemic Attack 48 48
Pericarditis 47 47
Pseudoaneurysm 46 46
Insufficient Information 44 44
Vascular Dissection 42 42
Bradycardia 42 42
Low Blood Pressure/ Hypotension 41 41
Air Embolism 40 40
Laceration(s) of Esophagus 34 34
Complete Heart Block 32 32
Tachycardia 32 32
Hemorrhage/Bleeding 28 28
Vasoconstriction 27 27
Myocardial Infarction 26 26
Hematoma 25 25
Heart Failure/Congestive Heart Failure 24 24
Perforation of Vessels 23 23
Paresis 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Cardiogenic Shock 16 16
Pulmonary Edema 16 16
Respiratory Failure 14 14
Blood Loss 13 13
Asystole 12 12
Unspecified Tissue Injury 12 12
Pleural Effusion 12 12
Sepsis 12 12
Thrombosis 11 11
Inflammation 11 11
Pain 11 11
Ischemia Stroke 11 11
Nerve Damage 10 10
Pneumothorax 10 10
ST Segment Elevation 9 9
Ventricular Tachycardia 9 9
Perforation of Esophagus 9 9
Heart Failure 8 8
Rupture 7 7
Unspecified Nervous System Problem 7 7
Partial thickness (Second Degree) Burn 7 7
Full thickness (Third Degree) Burn 7 7
Pulmonary Embolism 6 6
Encephalopathy 5 5
Dyspnea 5 5
Non specific EKG/ECG Changes 5 5
Pneumonia 5 5
No Patient Involvement 5 5
Respiratory Tract Infection 4 4
Embolism 4 4
Erosion 4 4
Chest Pain 4 4
Burn(s) 3 3
Atrial Tachycardia 3 3
Fever 3 3
Failure of Implant 3 3
Injury 3 3
Exit Block 3 3
Foreign Body In Patient 3 3
Renal Impairment 3 3
Mitral Valve Insufficiency/ Regurgitation 2 2
Embolism/Embolus 2 2
Obstruction/Occlusion 2 2
Unspecified Infection 2 2
Mitral Insufficiency 2 2
Pulmonary Dysfunction 2 2
Pyrosis/Heartburn 2 2
High Blood Pressure/ Hypertension 2 2
Atrial Fibrillation 2 2
Adult Respiratory Distress Syndrome 2 2
Dysphagia/ Odynophagia 2 2
Bacterial Infection 1 1
Syncope 1 1
Apnea 1 1
Hypoxia 1 1
Hemoptysis 1 1
Endocarditis 1 1
Eye Injury 1 1
Embolus 1 1
Neurological Deficit/Dysfunction 1 1
Renal Failure 1 1
Ventilator Dependent 1 1
Hypovolemia 1 1

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