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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
31 45 57 38 63 85 85 54 46 35 30 33 39 25 22 6

MDR Year MDR Reports MDR Events
2014 798 798
2015 1189 1189
2016 1010 1010
2017 1115 1115
2018 975 975
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
Adverse Event Without Identified Device or Use Problem 3550 3550
Patient Device Interaction Problem 2769 2769
Insufficient Information 849 849
Material Puncture/Hole 675 675
Device Operates Differently Than Expected 359 359
Device Displays Incorrect Message 313 313
High Readings 309 309
Contamination /Decontamination Problem 296 296
Incorrect, Inadequate or Imprecise Result or Readings 267 267
Signal Artifact/Noise 213 213
Device Contamination with Chemical or Other Material 212 212
Coagulation in Device or Device Ingredient 211 211
Break 196 196
Temperature Problem 196 196
Failure to Sense 188 188
Device Contamination with Body Fluid 176 176
Appropriate Term/Code Not Available 167 167
Positioning Problem 132 132
Communication or Transmission Problem 119 119
Charred 111 111
Hole In Material 109 109
Noise, Audible 104 104
Crack 102 102
No Display/Image 101 101
High impedance 89 89
Entrapment of Device 83 83
Improper or Incorrect Procedure or Method 71 71
Electrical Shorting 71 71
Obstruction of Flow 71 71
Material Integrity Problem 70 70
Insufficient Cooling 70 70
Device Sensing Problem 68 68
Material Protrusion/Extrusion 61 61
Material Split, Cut or Torn 61 61
Tear, Rip or Hole in Device Packaging 60 60
Protective Measures Problem 58 58
Display or Visual Feedback Problem 58 58
Bent 50 50
Sharp Edges 50 50
Scratched Material 49 49
Material Twisted/Bent 48 48
Detachment of Device or Device Component 41 41
Device Remains Activated 41 41
Material Separation 40 40
Mechanical Jam 37 37
Impedance Problem 36 36
Sticking 36 36
Device Inoperable 35 35
Delivered as Unsterile Product 33 33
Device Alarm System 32 32
Defective Device 32 32
Material Deformation 29 29
Erratic or Intermittent Display 28 28
Overheating of Device 28 28
Air Leak 26 26
Partial Blockage 26 26
Device Issue 26 26
Human-Device Interface Problem 26 26
Physical Resistance 24 24
Unable to Obtain Readings 24 24
Contamination 23 23
Image Orientation Incorrect 23 23
Leak/Splash 23 23
Mechanical Problem 23 23
Cut In Material 23 23
Expiration Date Error 23 23
Complete Blockage 20 20
Occlusion Within Device 20 20
Use of Device Problem 20 20
Difficult to Remove 18 18
Inflation Problem 18 18
Connection Problem 18 18
Infusion or Flow Problem 18 18
Fluid/Blood Leak 17 17
Electrical /Electronic Property Problem 17 17
Fracture 16 16
Kinked 16 16
Difficult To Position 16 16
Material Perforation 16 16
Separation Problem 16 16
Torn Material 15 15
Packaging Problem 15 15
Failure to Read Input Signal 15 15
Material Opacification 15 15
Output Problem 14 14
Therapeutic or Diagnostic Output Failure 14 14
Device Handling Problem 14 14
Improper Flow or Infusion 14 14
Manufacturing, Packaging or Shipping Problem 13 13
Over-Sensing 13 13
Peeled/Delaminated 13 13
Failure to Deliver Energy 13 13
Thermal Decomposition of Device 12 12
Deflation Problem 12 12
Device Dislodged or Dislocated 12 12
Fail-Safe Did Not Operate 11 11
Material Frayed 11 11
Device Expiration Issue 10 10
Image Display Error/Artifact 10 10
Material Discolored 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Tamponade 4362 4362
No Clinical Signs, Symptoms or Conditions 1656 1656
No Consequences Or Impact To Patient 1622 1622
No Known Impact Or Consequence To Patient 751 752
Low Blood Pressure/ Hypotension 714 714
Pericardial Effusion 678 678
No Code Available 580 580
Stroke/CVA 442 442
Cardiac Arrest 362 362
Fistula 356 356
Death 353 353
Heart Block 286 286
Cardiac Perforation 233 233
Complete Heart Block 164 164
Paralysis 136 136
Hemorrhage/Bleeding 130 130
Arrhythmia 125 125
Transient Ischemic Attack 121 121
Hematoma 117 117
Stenosis 99 99
Pseudoaneurysm 93 93
Perforation 89 89
Ventricular Tachycardia 76 76
Ventricular Fibrillation 72 72
Vascular Dissection 72 72
Air Embolism 67 67
Bradycardia 66 66
Tachycardia 62 62
Chest Pain 60 60
Thrombosis/Thrombus 60 60
Ischemic Heart Disease 59 59
Thrombosis 57 57
Pain 57 57
Sepsis 55 55
Myocardial Infarction 55 55
Atrial Fibrillation 53 53
Heart Failure 49 49
Nerve Damage 48 48
Pericarditis 47 47
Laceration(s) of Esophagus 45 45
Insufficient Information 44 44
ST Segment Elevation 44 44
Injury 42 42
No Information 41 41
Pulmonary Edema 41 41
No Patient Involvement 34 34
Cardiogenic Shock 33 33
Inflammation 33 33
Perforation of Vessels 32 32
Blood Loss 32 32
Not Applicable 31 31
Thrombus 31 31
Pneumothorax 31 31
Pleural Effusion 29 29
Dyspnea 29 29
Embolism 28 28
Fever 28 28
Bleeding 28 28
Vasoconstriction 28 28
Paresis 27 27
Unspecified Infection 26 26
Perforation of Esophagus 25 25
Heart Failure/Congestive Heart Failure 24 24
Pneumonia 23 23
Atrial Tachycardia 22 22
Pulmonary Embolism 20 20
Tissue Damage 19 19
Rupture 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Respiratory Failure 17 17
Test Result 17 17
Vomiting 17 17
Pulmonary Valve Stenosis 17 17
Nausea 16 16
High Blood Pressure/ Hypertension 16 16
Full thickness (Third Degree) Burn 15 15
Vascular System (Circulation), Impaired 15 15
Partial thickness (Second Degree) Burn 14 14
Aortic Dissection 14 14
Infarction, Cerebral 14 14
Respiratory Distress 14 14
Ischemia 13 13
Abdominal Pain 13 13
Congestive Heart Failure 13 13
Complaint, Ill-Defined 13 13
Abdominal Distention 12 12
Unspecified Tissue Injury 12 12
Asystole 12 12
Multiple Organ Failure 11 11
Ischemia Stroke 11 11
Constipation 11 11
Occlusion 11 11
Urinary Tract Infection 11 11
Weakness 10 10
Renal Failure 10 10
Thromboembolism 10 10
Hypervolemia 10 10
Discomfort 10 10
Low Oxygen Saturation 10 10
Loss of consciousness 9 9

Recalls
Manufacturer Recall Class Date Posted
1 BioSense Webster, Inc. II Nov-19-2009
2 Biosense Webster, Inc. II Dec-07-2017
3 Biosense Webster, Inc. II Oct-27-2017
4 Biosense Webster, Inc. II Oct-27-2014
5 Biosense Webster, Inc. II Sep-12-2011
6 Boston Scientific Corp II Jan-27-2011
7 Boston Scientific Corp II Mar-17-2010
8 Boston Scientific Corp II Jan-14-2009
9 Boston Scientific Corporation II Nov-01-2010
10 Medtronic Inc. Cardiac Rhythm Disease Management II Sep-17-2015
11 St Jude Medical II Sep-16-2011
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