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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search show TPLC since Back to Search Results
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
BAYLIS MEDICAL COMPANY INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOSENSE WEBSTER, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOTRONICK, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CATHRXLTD
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH, LLC.
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC
  SUBSTANTIALLY EQUIVALENT 2
SYNAPTIC MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
6 1 1 3 7 3

MDR Year MDR Reports MDR Events
2017 458 458
2018 723 723
2019 669 669
2020 651 651
2021 625 625
2022 495 495

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1615 1615
Material Twisted/Bent 465 465
Patient Device Interaction Problem 168 168
Material Deformation 167 167
Material Integrity Problem 140 140
Entrapment of Device 140 140
Difficult to Remove 91 91
Appropriate Term/Code Not Available 77 77
Kinked 68 68
Material Separation 58 58
Fracture 55 55
Break 54 54
Detachment of Device or Device Component 53 53
Material Frayed 48 48
Signal Artifact/Noise 38 38
Fluid/Blood Leak 35 35
Device Contamination with Chemical or Other Material 30 30
Mechanical Jam 29 29
Device Sensing Problem 25 25
Activation, Positioning or Separation Problem 25 25
Device Operates Differently Than Expected 24 24
Contamination /Decontamination Problem 23 23
Defective Device 23 23
Communication or Transmission Problem 22 22
Insufficient Information 22 22
Material Split, Cut or Torn 20 20
Detachment Of Device Component 20 20
Leak/Splash 20 20
Positioning Problem 19 19
Improper Flow or Infusion 17 17
Failure to Sense 17 17
Failure to Capture 15 15
Display or Visual Feedback Problem 14 14
Delivered as Unsterile Product 14 14
Difficult to Insert 14 14
Device Displays Incorrect Message 13 13
Material Perforation 12 12
Material Protrusion/Extrusion 12 12
Device Dislodged or Dislocated 11 11
Tear, Rip or Hole in Device Packaging 11 11
Mechanical Problem 11 11
Component Misassembled 11 11
Material Puncture/Hole 10 10
Use of Device Problem 10 10
Device-Device Incompatibility 10 10
Output Problem 10 10
Poor Quality Image 9 9
Compatibility Problem 8 8
Failure to Unfold or Unwrap 8 8
Sharp Edges 8 8
Noise, Audible 8 8
Device Issue 7 7
Knotted 7 7
Electrical /Electronic Property Problem 7 7
Coagulation in Device or Device Ingredient 7 7
High impedance 6 6
Hole In Material 6 6
Contamination 6 6
No Display/Image 6 6
Pacing Problem 6 6
Device Contamination with Body Fluid 6 6
Defective Component 6 6
Obstruction of Flow 6 6
Data Problem 6 6
Separation Problem 5 5
Expiration Date Error 5 5
Device Damaged by Another Device 5 5
Packaging Problem 5 5
Mechanics Altered 5 5
Material Rupture 5 5
Bent 5 5
Air Leak 4 4
Crack 4 4
Temperature Problem 4 4
Device Packaging Compromised 4 4
Difficult to Open or Remove Packaging Material 4 4
Physical Resistance 4 4
High Readings 4 4
Device Operational Issue 4 4
Connection Problem 3 3
Failure to Advance 3 3
Difficult to Advance 3 3
Therapeutic or Diagnostic Output Failure 3 3
Torn Material 3 3
Inflation Problem 3 3
Insufficient Cooling 3 3
Difficult to Flush 3 3
No Device Output 3 3
Fail-Safe Did Not Operate 3 3
No Apparent Adverse Event 3 3
Scratched Material 2 2
Device Handling Problem 2 2
No Pacing 2 2
Material Too Soft/Flexible 2 2
Power Conditioning Problem 2 2
Self-Activation or Keying 2 2
Failure to Analyze Signal 2 2
Material Too Rigid or Stiff 2 2
Unable to Obtain Readings 2 2
Over-Sensing 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 625 625
No Consequences Or Impact To Patient 615 615
Cardiac Perforation 572 572
Cardiac Tamponade 487 487
Pericardial Effusion 421 421
No Known Impact Or Consequence To Patient 390 390
Low Blood Pressure/ Hypotension 248 248
Stroke/CVA 109 109
Death 97 97
Hematoma 82 84
No Code Available 77 77
Fistula 54 56
Cardiac Arrest 49 49
Pseudoaneurysm 46 46
Chest Pain 41 41
Vascular Dissection 41 41
Arrhythmia 40 40
Hemorrhage/Bleeding 38 38
No Patient Involvement 38 38
Heart Block 36 36
Air Embolism 25 25
Tissue Damage 24 24
Transient Ischemic Attack 24 24
Tachycardia 21 21
Complete Heart Block 21 21
Perforation 21 21
Paralysis 19 19
Dyspnea 18 18
ST Segment Elevation 18 18
Thrombus 17 17
Blood Loss 17 17
Hemoptysis 17 17
Insufficient Information 17 17
Non specific EKG/ECG Changes 16 16
Vascular System (Circulation), Impaired 16 16
Inflammation 15 15
Thrombosis/Thrombus 15 15
Unspecified Tissue Injury 14 14
Embolism 14 14
Bradycardia 13 13
Myocardial Infarction 13 13
Great Vessel Perforation 13 13
Ischemia Stroke 13 13
Vaso-Vagal Response 12 12
Rupture 12 12
Nerve Damage 12 12
Fever 11 11
Heart Failure 11 11
Thrombosis 11 11
Ventricular Fibrillation 11 11
Ventricular Tachycardia 11 11
Embolism/Embolus 11 11
Pericarditis 10 10
Pneumonia 10 10
Atrial Fibrillation 9 9
Cardiopulmonary Arrest 9 9
Perforation of Vessels 9 9
Cardiogenic Shock 9 9
Mitral Valve Insufficiency/ Regurgitation 9 9
Device Embedded In Tissue or Plaque 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Stenosis 8 8
Respiratory Failure 8 8
Pleural Effusion 8 8
Paresis 7 7
Pneumothorax 7 7
Pulmonary Edema 7 7
Unspecified Infection 7 7
Loss of consciousness 7 7
Foreign Body In Patient 7 7
Diminished Pulse Pressure 6 6
Laceration(s) of Esophagus 6 6
Physical Entrapment 6 6
Injury 6 6
Dizziness 6 6
Sepsis 6 6
Not Applicable 6 6
Partial thickness (Second Degree) Burn 6 6
Vasoconstriction 5 5
Discomfort 5 5
Complaint, Ill-Defined 5 5
Aortic Dissection 5 5
Neurological Deficit/Dysfunction 5 5
Atrial Flutter 5 5
Embolus 4 4
Pain 4 4
Hypoxia 4 4
Low Oxygen Saturation 4 4
Weakness 4 4
No Information 4 4
Retroperitoneal Hemorrhage 4 4
Heart Failure/Congestive Heart Failure 4 4
Foreign Body Embolism 3 3
Visual Disturbances 3 3
Swelling 3 3
Coma 3 3
Obstruction/Occlusion 3 3
Confusion/ Disorientation 3 3
Hemothorax 3 3
High Blood Pressure/ Hypertension 3 3

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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