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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
Regulation Description Electrode recording catheter or electrode recording probe.
Product CodeDRF
Regulation Number 870.1220
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT LABORATORIES
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 1
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH, LLC.
  SUBSTANTIALLY EQUIVALENT 5
MEDFACT ENGINEERING GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
ST. JUDE MEDICAL (ABBOTT LABORATORIES)
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
2 6 1 1 3 0

MDR Year MDR Reports MDR Events
2016 383 383
2017 458 458
2018 723 723
2019 670 670
2020 651 651

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1432 1432
Material Twisted/Bent 282 282
Catheter 110 110
Appropriate Term/Code Not Available 103 103
Material Deformation 99 99
Entrapment of Device 90 90
Material Integrity Problem 83 83
Difficult to Remove 74 74
Kinked 69 69
Insufficient Information 65 65
Break 51 51
Device Operates Differently Than Expected 44 44
Detachment of Device or Device Component 39 39
Material Separation 33 33
Electrode 28 28
Device Contamination with Chemical or Other Material 28 28
Material Frayed 27 27
Device Sensing Problem 25 25
Fluid Leak 25 25
Detachment Of Device Component 24 24
Fracture 22 22
Device Displays Incorrect Message 20 20
Signal Artifact/Noise 19 19
Mechanical Jam 19 19
Positioning Problem 18 18
Material Split, Cut or Torn 14 14
Noise, Audible 14 14
Patient Device Interaction Problem 14 14
Failure to Sense 14 14
Communication or Transmission Problem 13 13
Sticking 13 13
Activation, Positioning or SeparationProblem 12 12
Improper Flow or Infusion 12 12
Defective Device 11 11
Contamination /Decontamination Problem 11 11
Knotted 11 11
Component Misassembled 11 11
Device Dislodged or Dislocated 10 10
Tip 9 9
Failure to Capture 9 9
Difficult to Insert 8 8
Delivered as Unsterile Product 8 8
Sharp Edges 8 8
Failure to Unfold or Unwrap 8 8
Use of Device Problem 8 8
Bent 8 8
No Display/Image 7 7
Hole In Material 7 7
Device Issue 7 7
Poor Quality Image 7 7
Electrical /Electronic Property Problem 7 7
Coagulation in Device or Device Ingredient 7 7
Contamination 6 6
Pacing Problem 6 6
Defective Component 6 6
Device-Device Incompatibility 6 6
Improper or Incorrect Procedure or Method 6 6
Tear, Rip or Hole in Device Packaging 5 5
High impedance 5 5
Device Alarm System 5 5
Physical Resistance 5 5
Device Damaged by Another Device 5 5
Device Packaging Compromised 5 5
Ring 5 5
Air Leak 5 5
No Apparent Adverse Event 5 5
Material Protrusion/Extrusion 5 5
Temperature Problem 5 5
Output Problem 4 4
Packaging Problem 4 4
Torn Material 4 4
Display or Visual Feedback Problem 4 4
Crack 4 4
Mechanical Problem 4 4
Material Puncture/Hole 4 4
Device Operational Issue 4 4
Expiration Date Error 4 4
Shaft 4 4
Leak/Splash 4 4
Device Damaged Prior to Use 4 4
Device Inoperable 4 4
Material Rupture 4 4
Difficult to Advance 4 4
Data Problem 4 4
Scratched Material 4 4
Fail-Safe Did Not Operate 3 3
Malposition of Device 3 3
Connection Problem 3 3
Mechanics Altered 3 3
Self-Activation or Keying 3 3
Power Conditioning Problem 3 3
Failure to Advance 3 3
Dent in Material 3 3
Wire 3 3
Material Perforation 3 3
Component Missing 3 3
Wrinkled 3 3
No Device Output 3 3
Unsealed Device Packaging 3 3
Pad 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 655 655
Cardiac Perforation 548 548
No Known Impact Or Consequence To Patient 429 429
Cardiac Tamponade 401 401
Pericardial Effusion 332 332
Low Blood Pressure/ Hypotension 227 227
Death 113 113
No Code Available 83 83
Stroke/CVA 78 78
Hematoma 63 63
Fistula 52 52
No Patient Involvement 48 48
Cardiac Arrest 41 41
Vascular Dissection 37 37
Pseudoaneurysm 36 36
No Clinical Signs, Symptoms or Conditions 33 33
Arrhythmia 31 31
Chest Pain 30 30
Tissue Damage 29 29
Hemorrhage/Bleeding 24 24
ST Segment Elevation 24 24
Complete Heart Block 23 23
Air Embolism 20 20
Blood Loss 19 19
Thrombus 18 18
Transient Ischemic Attack 17 17
Perforation 17 17
Vascular System (Circulation), Impaired 17 17
Dyspnea 16 16
Thrombosis 15 15
Embolism 15 15
Hemoptysis 14 14
Paralysis 14 14
Tachycardia 13 13
Vaso-Vagal Response 13 13
Ventricular Tachycardia 13 13
Inflammation 13 13
Heart Failure 12 12
Device Embedded In Tissue or Plaque 11 11
Cardiopulmonary Arrest 11 11
Partial thickness (Second Degree) Burn 11 11
Fever 10 10
No Information 10 10
Pneumothorax 10 10
Atrial Fibrillation 10 10
Bradycardia 9 9
Nerve Damage 9 9
Great Vessel Perforation 9 9
Pleural Effusion 9 9
Pneumonia 8 8
Injury 8 8
Myocardial Infarction 8 8
Perforation of Vessels 8 8
Physical Entrapment 7 7
Unspecified Infection 7 7
Pain 7 7
Pulmonary Edema 7 7
Ventricular Fibrillation 7 7
Dizziness 6 6
Stenosis 6 6
Foreign Body In Patient 6 6
Not Applicable 6 6
Respiratory Failure 6 6
Sepsis 6 6
Paresis 6 6
Neurological Deficit/Dysfunction 5 5
Aortic Dissection 5 5
Vasoconstriction 5 5
Complaint, Ill-Defined 5 5
Cardiogenic Shock 5 5
Weakness 5 5
Hemothorax 5 5
Infarction, Cerebral 5 5
Embolus 4 4
Mitral Insufficiency 4 4
Discomfort 4 4
Rupture 4 4
Loss of consciousness 4 4
Atrial Perforation 3 3
Occlusion 3 3
Swelling 3 3
High Blood Pressure/ Hypertension 3 3
Congestive Heart Failure 3 3
Vessel Or Plaque, Device Embedded In 3 3
Pulmonary Embolism 3 3
Full thickness (Third Degree) Burn 3 3
Thromboembolism 3 3
Laceration(s) of Esophagus 3 3
Heart Block 3 3
Blurred Vision 2 2
Tricuspid Regurgitation 2 2
Diminished Pulse Pressure 2 2
Nervous System Injury 2 2
Respiratory Distress 2 2
Hypoxia 2 2
Electro-Mechanical Dissociation 2 2
Laceration(s) 2 2
Nausea 2 2
Headache 2 2
Bacterial Infection 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Sep-19-2018
2 Irvine Biomedical Inc, a St. Jude Medical Co. II Sep-24-2020
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