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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)
2016 2017 2018 2019 2020 2021
54 46 35 30 33 11

MDR Year MDR Reports MDR Events
2016 1010 1010
2017 1115 1115
2018 975 975
2019 1123 1123
2020 1182 1182
2021 281 281

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2770 2770
Material Puncture/Hole 430 430
Insufficient Information 405 405
Patient Device Interaction Problem 297 297
Device Operates Differently Than Expected 178 178
Coagulation in Device or Device Ingredient 173 173
Device Contamination with Chemical or Other Material 155 155
Appropriate Term/Code Not Available 132 132
Device Displays Incorrect Message 129 129
Temperature Problem 82 82
Hole In Material 75 75
Break 58 58
Contamination /Decontamination Problem 57 57
High Readings 52 52
Crack 52 52
Material Split, Cut or Torn 50 50
Sharp Edges 48 48
Signal Artifact/Noise 46 46
No Display/Image 45 45
Improper or Incorrect Procedure or Method 42 42
High impedance 41 41
Entrapment of Device 40 40
Device Remains Activated 40 40
Noise, Audible 37 37
Device Sensing Problem 35 35
Detachment of Device or Device Component 31 31
Communication or Transmission Problem 30 30
Device Contamination with Body Fluid 27 27
Device Issue 26 26
Tear, Rip or Hole in Device Packaging 25 25
Device Alarm System 23 23
Material Separation 21 21
Failure to Sense 20 20
Material Protrusion/Extrusion 20 20
Positioning Problem 20 20
Impedance Problem 18 18
Scratched Material 17 17
Unable to Obtain Readings 17 17
Delivered as Unsterile Product 17 17
Charred 16 16
Material Integrity Problem 16 16
Air Leak 15 15
Use of Device Problem 15 15
Occlusion Within Device 15 15
Display or Visual Feedback Problem 14 14
Fracture 14 14
Incorrect, Inadequate or Imprecise Resultor Readings 13 13
Device Handling Problem 13 13
Material Deformation 13 13
Device Inoperable 13 13
Separation Problem 12 12
Difficult to Remove 12 12
Material Perforation 12 12
Defective Device 12 12
Bent 11 11
Mechanical Jam 11 11
Fail-Safe Did Not Operate 11 11
Sticking 10 10
Improper Flow or Infusion 10 10
Obstruction of Flow 10 10
Expiration Date Error 9 9
No Apparent Adverse Event 9 9
Leak/Splash 9 9
Partial Blockage 9 9
Contamination 9 9
Failure to Read Input Signal 9 9
High Sensing Threshold 9 9
Electrical Shorting 9 9
Over-Sensing 8 8
Thermal Decomposition of Device 8 8
Insufficient Cooling 8 8
Material Frayed 8 8
Physical Property Issue 8 8
Physical Resistance 8 8
Device Expiration Issue 8 8
Overheating of Device 8 8
Device Operational Issue 7 7
Protective Measures Problem 7 7
Restricted Flow rate 7 7
Detachment Of Device Component 7 7
Failure to Select Signal 7 7
Connection Problem 7 7
Self-Activation or Keying 6 6
Pacing Problem 6 6
Peeled/Delaminated 6 6
Torn Material 6 6
Device Dislodged or Dislocated 6 6
Cut In Material 6 6
Unsealed Device Packaging 6 6
Deflation Problem 6 6
Fluid Leak 5 5
Component Missing 5 5
Failure to Unfold or Unwrap 5 5
Failure to Shut Off 5 5
Therapeutic or Diagnostic Output Failure 5 5
Image Orientation Incorrect 5 5
Image Display Error/Artifact 4 4
Electrical /Electronic Property Problem 4 4
Material Discolored 4 4
Device Packaging Compromised 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Tamponade 2204 2204
No Consequences Or Impact To Patient 1252 1252
No Code Available 543 543
No Known Impact Or Consequence To Patient 409 409
Low Blood Pressure/ Hypotension 378 378
Death 251 251
Pericardial Effusion 202 202
Stroke/CVA 194 194
Fistula 191 191
Cardiac Arrest 169 169
No Clinical Signs, Symptoms or Conditions 126 126
Complete Heart Block 122 122
Arrhythmia 81 81
Cardiac Perforation 66 66
Hemorrhage/Bleeding 55 55
Paralysis 55 55
Thrombosis 52 52
Pseudoaneurysm 50 50
Hematoma 45 45
Ventricular Tachycardia 42 42
Stenosis 42 42
Transient Ischemic Attack 41 41
Ventricular Fibrillation 37 37
Injury 36 36
Vascular Dissection 36 36
Perforation 35 35
Myocardial Infarction 34 34
Not Applicable 31 31
Blood Loss 31 31
ST Segment Elevation 31 31
Air Embolism 30 30
Bradycardia 28 28
Chest Pain 26 26
Laceration(s) of Esophagus 23 23
Heart Failure 23 23
Heart Block 23 23
No Information 22 22
Atrial Fibrillation 22 22
Inflammation 22 22
Sepsis 21 21
Thrombus 18 18
Perforation of Vessels 17 17
Pain 16 16
No Patient Involvement 16 16
Nerve Damage 15 15
Pleural Effusion 15 15
Tachycardia 15 15
Embolism 14 14
Cardiogenic Shock 14 14
Infarction, Cerebral 13 13
Pulmonary Valve Stenosis 13 13
Dyspnea 13 13
Pneumothorax 12 12
Full thickness (Third Degree) Burn 11 11
Rupture 11 11
Perforation of Esophagus 11 11
Partial thickness (Second Degree) Burn 11 11
Insufficient Information 11 11
Tissue Damage 10 10
Thromboembolism 9 9
Aortic Dissection 9 9
High Blood Pressure/ Hypertension 9 9
Ischemia 8 8
Fluid Discharge 8 8
Thrombosis/Thrombus 8 8
Pneumonia 8 8
Respiratory Tract Infection 8 8
Urinary Tract Infection 7 7
Unspecified Infection 7 7
Vascular System (Circulation), Impaired 7 7
Fever 7 7
Atrial Tachycardia 7 7
Pulmonary Embolism 7 7
Renal Failure 7 7
Discharge 7 7
Coma 6 6
Congestive Heart Failure 6 6
Exit Block 6 6
Atrial Perforation 6 6
Weakness 6 6
Pulmonary Edema 5 5
Dizziness 5 5
Discomfort 5 5
Complaint, Ill-Defined 5 5
Hypoxia 5 5
Hemothorax 5 5
Hypervolemia 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Cancer 5 5
Encephalopathy 5 5
Occlusion 5 5
Paresis 5 5
Ulceration 4 4
Low Oxygen Saturation 4 4
Intracranial Hemorrhage 4 4
Burn(s) 4 4
Cardiopulmonary Arrest 4 4
Embolus 4 4
Hemoptysis 4 4
Vomiting 4 4

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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