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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, electrode recording, or probe, electrode recording
Product CodeDRF
Regulation Number 870.1220
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ACCESS POINT TECHNOLOGIES EP, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 10
BIOTRONICK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CATHRXLTD
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH, LLC.
  SUBSTANTIALLY EQUIVALENT 6
MEDFACT ENGINEERING GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC ABLATION FRONTIERS, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
RHYTHMIA MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 2
SHANGHAI MICROPORT EP MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 9
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SYNAPTIC MEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 2 6 1 1 3 7 3 1 0

MDR Year MDR Reports MDR Events
2014 349 349
2015 325 325
2016 383 383
2017 458 458
2018 723 723
2019 669 669
2020 651 651
2021 625 625
2022 613 613
2023 686 686
2024 159 159

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2238 2238
Material Twisted/Bent 581 581
Material Deformation 318 318
Patient Device Interaction Problem 265 265
Entrapment of Device 217 217
Insufficient Information 202 202
Material Integrity Problem 167 167
Difficult to Remove 141 141
Appropriate Term/Code Not Available 116 116
Device Operates Differently Than Expected 110 110
Break 110 110
Signal Artifact/Noise 103 103
Fracture 94 94
Material Separation 81 81
Kinked 75 75
Detachment of Device or Device Component 73 73
Device Contamination with Chemical or Other Material 72 72
Device Displays Incorrect Message 61 61
Communication or Transmission Problem 54 54
Material Frayed 53 53
Mechanical Problem 48 48
Fluid/Blood Leak 47 47
Positioning Problem 43 43
Mechanical Jam 42 42
Detachment Of Device Component 42 42
Sticking 41 41
Noise, Audible 41 41
Activation, Positioning or Separation Problem 40 40
Compatibility Problem 39 39
Contamination /Decontamination Problem 37 37
Device Sensing Problem 34 34
Material Protrusion/Extrusion 30 30
Defective Device 30 30
Failure to Sense 28 28
Display or Visual Feedback Problem 27 27
Improper Flow or Infusion 26 26
Difficult to Insert 25 25
Leak/Splash 24 24
Material Perforation 23 23
Device-Device Incompatibility 22 22
Material Split, Cut or Torn 20 20
Delivered as Unsterile Product 20 20
Contamination 18 18
Bent 18 18
Tear, Rip or Hole in Device Packaging 18 18
Device Dislodged or Dislocated 16 16
Use of Device Problem 15 15
Failure to Capture 15 15
Coagulation in Device or Device Ingredient 15 15
No Display/Image 14 14
Improper or Incorrect Procedure or Method 14 14
Material Puncture/Hole 14 14
Scratched Material 14 14
Poor Quality Image 13 13
Knotted 13 13
High impedance 12 12
Device Inoperable 12 12
Device Contamination with Body Fluid 12 12
Connection Problem 12 12
Output Problem 12 12
Packaging Problem 11 11
Manufacturing, Packaging or Shipping Problem 11 11
Temperature Problem 11 11
Component Misassembled 11 11
Obstruction of Flow 10 10
Hole In Material 10 10
Electrical /Electronic Property Problem 10 10
Defective Component 9 9
Failure to Unfold or Unwrap 8 8
Dent in Material 8 8
Air Leak 8 8
Device Alarm System 8 8
Difficult To Position 8 8
Device Handling Problem 8 8
Torn Material 8 8
Sharp Edges 8 8
Data Problem 7 7
No Apparent Adverse Event 7 7
Difficult to Advance 7 7
Overheating of Device 7 7
Physical Resistance 7 7
Device Issue 7 7
Failure to Advance 7 7
Malposition of Device 7 7
Unable to Obtain Readings 7 7
Retraction Problem 7 7
Wrinkled 6 6
Expiration Date Error 6 6
Pacing Problem 6 6
Unsealed Device Packaging 6 6
Excess Flow or Over-Infusion 6 6
Insufficient Cooling 6 6
Device Damaged by Another Device 6 6
Device Packaging Compromised 6 6
Electrical Shorting 6 6
Infusion or Flow Problem 6 6
Mechanics Altered 5 5
Difficult to Open or Close 5 5
Therapeutic or Diagnostic Output Failure 5 5
Protective Measures Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1135 1135
No Consequences Or Impact To Patient 823 823
Cardiac Tamponade 786 786
Cardiac Perforation 765 765
Pericardial Effusion 653 653
No Known Impact Or Consequence To Patient 537 537
Low Blood Pressure/ Hypotension 424 424
Stroke/CVA 161 161
Death 145 145
Fistula 106 108
Hematoma 106 108
No Code Available 98 98
Cardiac Arrest 76 76
Hemorrhage/Bleeding 72 72
Pseudoaneurysm 67 67
Chest Pain 64 64
No Patient Involvement 62 62
Vascular Dissection 60 60
Heart Block 55 55
Arrhythmia 55 55
Transient Ischemic Attack 52 52
Tachycardia 43 43
Perforation 40 40
Air Embolism 40 40
Insufficient Information 38 38
Tissue Damage 36 36
Thrombosis/Thrombus 32 32
Complete Heart Block 30 30
Hemoptysis 30 30
Bradycardia 27 27
Paralysis 27 27
ST Segment Elevation 26 26
Dyspnea 25 25
Foreign Body In Patient 25 25
Blood Loss 25 25
Partial thickness (Second Degree) Burn 24 24
Thrombosis 23 23
Rupture 22 22
Atrial Fibrillation 22 22
Non specific EKG/ECG Changes 21 21
Nerve Damage 21 21
Inflammation 20 20
No Information 20 20
Unspecified Tissue Injury 19 19
Thrombus 19 19
Fever 18 18
Embolism 18 18
Perforation of Vessels 17 17
Vascular System (Circulation), Impaired 17 17
Ischemia Stroke 16 16
Device Embedded In Tissue or Plaque 15 15
Physical Entrapment 15 15
Ventricular Fibrillation 15 15
Ventricular Tachycardia 15 15
Sepsis 14 14
Stenosis 14 14
Cardiopulmonary Arrest 14 14
Vaso-Vagal Response 14 14
Embolism/Embolus 14 14
Pericarditis 13 13
Myocardial Infarction 13 13
Heart Failure 13 13
Injury 13 13
Great Vessel Perforation 13 13
Pleural Effusion 13 13
Pneumothorax 13 13
Pneumonia 12 12
Pain 12 12
Atrial Flutter 11 11
Burn(s) 10 10
Complaint, Ill-Defined 10 10
Cardiogenic Shock 10 10
Mitral Valve Insufficiency/ Regurgitation 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Heart Failure/Congestive Heart Failure 10 10
Full thickness (Third Degree) Burn 10 10
Respiratory Failure 9 9
Vasoconstriction 9 9
Nausea 9 9
Ischemia 9 9
Laceration(s) 8 8
Unspecified Infection 8 8
High Blood Pressure/ Hypertension 8 8
Pulmonary Embolism 8 8
Paresis 8 8
Pulmonary Edema 8 8
Pulmonary Valve Stenosis 7 7
Neurological Deficit/Dysfunction 7 7
Swelling 7 7
Laceration(s) of Esophagus 7 7
Dizziness 7 7
Hemothorax 7 7
Loss of consciousness 7 7
Diaphoresis 7 7
Diminished Pulse Pressure 7 7
Thromboembolism 6 6
Not Applicable 6 6
Intracranial Hemorrhage 6 6
Infarction, Cerebral 6 6
Discomfort 6 6

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Sep-19-2018
2 Biosense Webster, Inc. II Apr-27-2015
3 Biosense Webster, Inc. II Mar-03-2015
4 Biosense Webster, Inc. II Jun-28-2013
5 Biosense Webster, Inc. II May-22-2012
6 Biosense Webster, Inc. III Aug-18-2011
7 Biosense Webster, Inc. II Jun-27-2011
8 Boston Scientific Corp II Dec-10-2014
9 Irvine Biomedical Inc, a St. Jude Medical Co. II Sep-24-2020
10 Medtronic Inc. II Nov-02-2015
11 St Jude Medical II Nov-06-2014
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