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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)
2017 2018 2019 2020 2021 2022
64 29 39 42 50 0

MDR Year MDR Reports MDR Events
2017 403 403
2018 423 423
2019 475 475
2020 389 389
2021 403 403

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 936 936
Temperature Problem 119 119
Patient Device Interaction Problem 110 110
Material Integrity Problem 109 109
Device Displays Incorrect Message 78 78
Break 66 66
Fluid Leak 52 52
Device Remains Activated 48 48
Device Operates Differently Than Expected 48 48
Improper Flow or Infusion 47 47
Communication or Transmission Problem 44 44
Leak/Splash 38 38
Insufficient Information 34 34
Data Problem 28 28
Defective Device 27 27
Signal Artifact/Noise 27 27
Poor Quality Image 24 24
Mechanics Altered 24 24
Positioning Problem 23 23
Impedance Problem 23 23
Noise, Audible 20 20
Device Sensing Problem 19 19
Failure to Deliver Energy 19 19
Kinked 18 18
Fracture 14 14
High impedance 14 14
Power Conditioning Problem 14 14
Device Contamination with Chemical or Other Material 14 14
Detachment of Device or Device Component 13 13
Bent 12 12
Crack 12 12
Failure to Power Up 11 11
Material Perforation 11 11
Obstruction of Flow 11 11
Thermal Decomposition of Device 10 10
Material Deformation 9 9
Output Problem 9 9
Activation, Positioning or SeparationProblem 8 8
Entrapment of Device 8 8
Difficult to Remove 8 8
Insufficient Flow or Under Infusion 7 7
No Display/Image 7 7
Tear, Rip or Hole in Device Packaging 7 7
Scratched Material 7 7
Electrical /Electronic Property Problem 6 6
Improper or Incorrect Procedure or Method 6 6
Failure to Sense 6 6
Overheating of Device 6 6
Mechanical Problem 5 5
Material Separation 5 5
Low impedance 5 5
Material Split, Cut or Torn 5 5
Appropriate Term/Code Not Available 5 5
Connection Problem 5 5
Material Protrusion/Extrusion 5 5
Material Twisted/Bent 5 5
Pressure Problem 4 4
Unexpected Shutdown 4 4
Device Contamination with Body Fluid 4 4
Material Puncture/Hole 4 4
Failure to Analyze Signal 3 3
No Device Output 3 3
Use of Device Problem 3 3
Display or Visual Feedback Problem 3 3
Detachment Of Device Component 3 3
Hole In Material 3 3
Therapeutic or Diagnostic Output Failure 3 3
Mechanical Jam 3 3
Optical Problem 3 3
Electrical Shorting 3 3
Human-Device Interface Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Device-Device Incompatibility 2 2
No Pacing 2 2
Excessive Heating 2 2
Unintended Electrical Shock 2 2
Image Display Error/Artifact 2 2
Difficult to Insert 2 2
Flushing Problem 2 2
Insufficient Heating 2 2
Delivered as Unsterile Product 2 2
Occlusion Within Device 2 2
Contamination 2 2
Charred 2 2
Sticking 2 2
Device Inoperable 2 2
Material Too Rigid or Stiff 2 2
Therapy Delivered to Incorrect Body Area 2 2
Unsealed Device Packaging 2 2
Loss of Power 1 1
Self-Activation or Keying 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Failure to Read Input Signal 1 1
Failure to Select Signal 1 1
Smoking 1 1
Defective Component 1 1
Radiofrequency Interference (RFI) 1 1
Device Issue 1 1
Cut In Material 1 1
High Readings 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 570 570
Cardiac Perforation 272 272
Cardiac Tamponade 262 262
No Clinical Signs, Symptoms or Conditions 208 208
No Known Impact Or Consequence To Patient 175 175
Pericardial Effusion 93 93
Stroke/CVA 80 80
Death 69 69
Low Blood Pressure/ Hypotension 63 63
No Code Available 59 59
Fistula 51 51
Pseudoaneurysm 41 41
Hematoma 31 31
Cardiac Arrest 28 28
Transient Ischemic Attack 27 27
Complete Heart Block 27 27
Hemorrhage/Bleeding 25 25
Arrhythmia 24 24
Paralysis 21 21
Chest Pain 20 20
Thrombosis 19 19
No Patient Involvement 19 19
Air Embolism 18 18
ST Segment Elevation 16 16
Nerve Damage 16 16
Insufficient Information 15 15
Laceration(s) of Esophagus 13 13
Stenosis 12 12
Pericarditis 11 11
Myocardial Infarction 11 11
Dyspnea 10 10
Vascular Dissection 10 10
Cardiogenic Shock 10 10
Heart Failure 10 10
Ventricular Tachycardia 10 10
Aortic Dissection 10 10
Tissue Damage 9 9
Thrombosis/Thrombus 9 9
Heart Block 9 9
Inflammation 9 9
Atrial Fibrillation 8 8
Ventricular Fibrillation 8 8
Blood Loss 8 8
Injury 7 7
Perforation of Esophagus 7 7
Burn(s) 6 6
Unspecified Infection 6 6
Sepsis 6 6
Pneumothorax 6 6
Thrombus 6 6
Pleural Effusion 6 6
Mitral Insufficiency 5 5
Pain 5 5
Pulmonary Embolism 5 5
Respiratory Tract Infection 5 5
Thromboembolism 5 5
Ischemia Stroke 4 4
Loss Of Pulse 4 4
Bradycardia 4 4
Embolus 4 4
Pneumonia 4 4
Perforation 4 4
Tachycardia 3 3
Pulmonary Edema 3 3
High Blood Pressure/ Hypertension 3 3
Congestive Heart Failure 3 3
Embolism 3 3
Respiratory Failure 3 3
Atrial Perforation 3 3
Discomfort 3 3
Weakness 3 3
Perforation of Vessels 3 3
Embolism/Embolus 3 3
Not Applicable 3 3
No Information 3 3
Partial thickness (Second Degree) Burn 3 3
Unspecified Heart Problem 3 3
Heart Failure/Congestive Heart Failure 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Retroperitoneal Hemorrhage 2 2
Renal Impairment 2 2
Device Embedded In Tissue or Plaque 2 2
Vaso-Vagal Response 2 2
Hypervolemia 2 2
Tissue Breakdown 2 2
Great Vessel Perforation 2 2
Numbness 2 2
Rupture 2 2
Low Oxygen Saturation 2 2
Electric Shock 2 2
Hematuria 2 2
Fever 2 2
Headache 2 2
Infarction, Cerebral 2 2
Atrial Flutter 2 2
Atrial Tachycardia 2 2
Paresis 2 2
Neurological Deficit/Dysfunction 2 2
Occlusion 2 2
Pulmonary Valve Stenosis 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation III Jan-08-2019
2 Boston Scientific Corporation II Aug-28-2018
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