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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)
2017 2018 2019 2020 2021 2022
46 35 30 33 39 10

MDR Year MDR Reports MDR Events
2017 1115 1115
2018 975 975
2019 1124 1124
2020 1182 1182
2021 1242 1242
2022 410 410

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2594 2594
Patient Device Interaction Problem 1188 1188
Material Puncture/Hole 551 551
High Readings 189 189
Coagulation in Device or Device Ingredient 171 171
Insufficient Information 144 144
Contamination /Decontamination Problem 132 132
Device Contamination with Chemical or Other Material 127 127
Appropriate Term/Code Not Available 113 113
Signal Artifact/Noise 94 94
Device Displays Incorrect Message 81 81
Device Contamination with Body Fluid 80 80
Device Operates Differently Than Expected 79 79
Hole In Material 65 65
Temperature Problem 65 65
Material Split, Cut or Torn 58 58
Failure to Sense 55 55
Incorrect, Inadequate or Imprecise Resultor Readings 54 54
Break 50 50
Sharp Edges 50 50
Crack 49 49
Entrapment of Device 46 46
Device Remains Activated 39 39
Device Sensing Problem 37 37
Detachment of Device or Device Component 34 34
Positioning Problem 33 33
Tear, Rip or Hole in Device Packaging 32 32
No Display/Image 32 32
High impedance 30 30
Communication or Transmission Problem 30 30
Electrical Shorting 28 28
Device Issue 26 26
Noise, Audible 23 23
Material Separation 22 22
Delivered as Unsterile Product 22 22
Display or Visual Feedback Problem 22 22
Insufficient Cooling 20 20
Material Protrusion/Extrusion 20 20
Impedance Problem 19 19
Defective Device 18 18
Material Integrity Problem 16 16
Mechanical Jam 15 15
Expiration Date Error 15 15
Improper or Incorrect Procedure or Method 15 15
Device Alarm System 15 15
Fracture 14 14
Material Twisted/Bent 14 14
Separation Problem 14 14
Material Deformation 13 13
Unable to Obtain Readings 13 13
Material Perforation 12 12
Charred 12 12
Air Leak 12 12
Contamination 12 12
Fail-Safe Did Not Operate 11 11
Scratched Material 10 10
Partial Blockage 10 10
Difficult to Remove 10 10
Complete Blockage 9 9
Image Orientation Incorrect 9 9
Material Opacification 9 9
Material Frayed 8 8
Thermal Decomposition of Device 8 8
Obstruction of Flow 8 8
High Sensing Threshold 8 8
Improper Flow or Infusion 8 8
No Apparent Adverse Event 8 8
Protective Measures Problem 7 7
Output Problem 7 7
Restricted Flow rate 7 7
Leak/Splash 7 7
Overheating of Device 7 7
Over-Sensing 7 7
Pacing Problem 7 7
Use of Device Problem 6 6
Physical Property Issue 6 6
Packaging Problem 5 5
Failure to Read Input Signal 5 5
Failure to Select Signal 5 5
Device Inoperable 5 5
Physical Resistance 5 5
Failure to Unfold or Unwrap 5 5
Connection Problem 5 5
Device-Device Incompatibility 5 5
Occlusion Within Device 5 5
Mechanical Problem 4 4
Product Quality Problem 4 4
Unsealed Device Packaging 4 4
Fluid Leak 4 4
Erratic or Intermittent Display 4 4
Bent 4 4
Detachment Of Device Component 4 4
Electrical /Electronic Property Problem 4 4
Failure to Deliver Energy 4 4
Device Operational Issue 4 4
Failure to Analyze Signal 4 4
Self-Activation or Keying 4 4
Low impedance 4 4
Cut In Material 4 4
Component Missing 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Tamponade 2444 2444
No Consequences Or Impact To Patient 1177 1177
No Clinical Signs, Symptoms or Conditions 527 527
No Code Available 521 521
No Known Impact Or Consequence To Patient 241 241
Stroke/CVA 224 224
Cardiac Arrest 191 191
Low Blood Pressure/ Hypotension 190 190
Death 187 187
Fistula 160 160
Pericardial Effusion 126 126
Heart Block 108 108
Complete Heart Block 89 89
Arrhythmia 84 84
Paralysis 74 74
Pseudoaneurysm 59 59
Cardiac Perforation 57 57
Vascular Dissection 48 48
Ventricular Fibrillation 48 48
Transient Ischemic Attack 44 44
Stenosis 43 43
Hemorrhage/Bleeding 37 37
Thrombosis 35 35
Hematoma 34 34
Bradycardia 34 34
Myocardial Infarction 31 31
Not Applicable 31 31
Thrombosis/Thrombus 30 30
Air Embolism 30 30
Laceration(s) of Esophagus 26 26
Perforation of Vessels 24 24
Blood Loss 24 24
Ventricular Tachycardia 23 23
Inflammation 20 20
ST Segment Elevation 20 20
Insufficient Information 20 20
Heart Failure 19 19
Tachycardia 18 18
Cardiogenic Shock 15 15
Pneumothorax 15 15
Paresis 14 14
Nerve Damage 14 14
Injury 14 14
Rupture 13 13
No Patient Involvement 13 13
Ischemic Heart Disease 13 13
Sepsis 13 13
Pleural Effusion 12 12
Chest Pain 12 12
Embolism 12 12
No Information 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Pericarditis 12 12
Infarction, Cerebral 11 11
Perforation 11 11
Pain 10 10
Dyspnea 9 9
Perforation of Esophagus 9 9
Vasoconstriction 8 8
Respiratory Failure 8 8
Thromboembolism 8 8
Atrial Fibrillation 8 8
Thrombus 8 8
Pulmonary Edema 7 7
Pulmonary Valve Stenosis 7 7
Pulmonary Embolism 7 7
Partial thickness (Second Degree) Burn 7 7
Full thickness (Third Degree) Burn 7 7
Respiratory Tract Infection 7 7
Urinary Tract Infection 7 7
Exit Block 6 6
Ischemia Stroke 6 6
Congestive Heart Failure 6 6
Hypoxia 6 6
High Blood Pressure/ Hypertension 6 6
Ischemia 5 5
Renal Failure 5 5
Pneumonia 5 5
Encephalopathy 5 5
Hypervolemia 5 5
Vascular System (Circulation), Impaired 4 4
Aortic Dissection 4 4
Asystole 4 4
Complaint, Ill-Defined 4 4
Erosion 4 4
Fever 4 4
Atrial Tachycardia 4 4
Burn(s) 3 3
Adult Respiratory Distress Syndrome 3 3
Embolus 3 3
Occlusion 3 3
Tissue Damage 3 3
Hemoptysis 3 3
Discomfort 3 3
Ulcer 3 3
Atrial Perforation 3 3
Unspecified Tissue Injury 3 3
Heart Failure/Congestive Heart Failure 2 2
Foreign Body In Patient 2 2
Device Embedded In Tissue or Plaque 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Biosense Webster, Inc. II Dec-07-2017
2 Biosense Webster, Inc. II Oct-27-2017
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