• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device catheter, steerable
Regulation Description Steerable catheter.
Product CodeDRA
Regulation Number 870.1280
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIOFOCUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FREUDENBERG MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
HANSEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC CRYOCATH LP
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2016 481 481
2017 625 625
2018 633 633
2019 700 700
2020 703 703
2021 613 613

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1487 1487
Leak/Splash 605 605
Air Leak 251 251
Gas Leak 235 235
Appropriate Term/Code Not Available 199 199
Material Twisted/Bent 190 190
Fluid Leak 180 180
Break 131 131
Material Integrity Problem 88 88
Mechanical Problem 79 79
Kinked 73 73
Failure to Advance 67 67
Improper or Incorrect Procedure or Method 63 63
Device Operates Differently Than Expected 62 62
Deformation Due to Compressive Stress 59 59
Difficult to Remove 57 57
Torn Material 51 51
Difficult to Insert 46 46
Material Split, Cut or Torn 46 46
Positioning Failure 45 45
Unintended Movement 41 41
Unstable 30 30
Difficult or Delayed Positioning 27 27
Loose or Intermittent Connection 27 27
Material Deformation 24 24
Detachment Of Device Component 23 23
Material Separation 21 21
Difficult to Advance 21 21
Device Contamination with Body Fluid 20 20
Noise, Audible 19 19
Insufficient Information 15 15
Off-Label Use 15 15
Crack 14 14
Device Contamination with Chemical or Other Material 14 14
Physical Resistance 14 14
Difficult To Position 11 11
Difficult to Flush 9 9
Product Quality Problem 8 8
Delivered as Unsterile Product 7 7
Physical Property Issue 7 7
Physical Resistance/Sticking 7 7
Device Damaged by Another Device 6 6
Tear, Rip or Hole in Device Packaging 5 5
Mechanical Jam 5 5
No Apparent Adverse Event 5 5
Compatibility Problem 4 4
Aspiration Issue 4 4
Device Markings/Labelling Problem 4 4
Entrapment of Device 4 4
Bent 4 4
Device Slipped 3 3
Activation, Positioning or SeparationProblem 3 3
Suction Problem 2 2
Difficult to Open or Close 2 2
Peeled/Delaminated 2 2
Signal Artifact/Noise 2 2
Loss of or Failure to Bond 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Device Expiration Issue 1 1
Material Frayed 1 1
Unsealed Device Packaging 1 1
Nonstandard Device 1 1
Sticking 1 1
Incorrect, Inadequate or Imprecise Resultor Readings 1 1
Retraction Problem 1 1
Material Rupture 1 1
Human-Device Interface Problem 1 1
Material Protrusion/Extrusion 1 1
Naturally Worn 1 1
Temperature Problem 1 1
Out-Of-Box Failure 1 1
Structural Problem 1 1
Defective Device 1 1
Failure to Disconnect 1 1
Detachment of Device or Device Component 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Device-Device Incompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 662 662
No Consequences Or Impact To Patient 508 508
Pericardial Effusion 351 351
Atrial Perforation 333 333
No Patient Involvement 319 319
No Clinical Signs, Symptoms or Conditions 305 305
Low Blood Pressure/ Hypotension 303 303
Cardiac Tamponade 261 261
Hematoma 163 164
Thrombosis 154 154
Air Embolism 134 134
Hemorrhage/Bleeding 123 123
Perforation 116 116
ST Segment Elevation 114 114
Pseudoaneurysm 111 111
Cardiac Perforation 99 99
Fistula 81 82
Death 70 70
Cardiac Arrest 62 62
Embolism 43 43
Vascular System (Circulation), Impaired 43 43
Tissue Damage 41 41
No Code Available 39 39
Thrombosis/Thrombus 36 36
Non specific EKG/ECG Changes 35 35
Stroke/CVA 33 33
Arrhythmia 32 32
Blood Loss 32 32
Pain 29 29
Bradycardia 28 28
Chest Pain 26 26
Insufficient Information 26 26
Heart Failure 23 23
Dyspnea 20 20
Respiratory Distress 18 18
Ventricular Fibrillation 15 15
Paralysis 15 15
Myocardial Infarction 14 14
High Blood Pressure/ Hypertension 14 14
Anemia 14 14
Neurological Deficit/Dysfunction 13 13
Hypoxia 12 12
Loss of consciousness 12 12
Inflammation 11 11
Test Result 10 10
Vaso-Vagal Response 9 9
Respiratory Failure 9 9
Perforation of Vessels 9 9
Unspecified Tissue Injury 9 9
Embolism/Embolus 8 8
Ventricular Tachycardia 8 8
Tachycardia 8 8
Exit Block 8 8
Fever 8 8
Paresis 8 8
Edema 8 8
Cardiopulmonary Arrest 7 7
Hemoptysis 7 7
Vascular Dissection 7 7
Dizziness 7 7
Shock 6 6
Pleural Effusion 6 6
Vasoconstriction 6 6
Great Vessel Perforation 6 6
Cardiogenic Shock 6 6
Heart Block 6 6
Heart Failure/Congestive Heart Failure 5 5
Thrombus 5 5
Palpitations 5 5
Pneumothorax 5 5
Nerve Damage 5 5
Intimal Dissection 5 5
Infarction, Cerebral 5 5
Pulmonary Embolism 4 4
Nausea 4 4
Mitral Regurgitation 4 4
Headache 4 4
Unspecified Infection 4 4
Confusion/ Disorientation 4 4
Transient Ischemic Attack 4 4
Tricuspid Regurgitation 4 4
Pneumonia 4 4
Vomiting 4 4
Weakness 4 4
Visual Disturbances 3 3
Stenosis 3 3
Brain Injury 3 3
Seizures 3 3
Swelling 3 3
Complete Heart Block 3 3
Numbness 3 3
Coma 3 3
Ischemia 3 3
Hemothorax 3 3
Muscle Weakness 3 3
Pulmonary Edema 3 3
Bacterial Infection 3 3
Atrial Fibrillation 3 3
Atrial Flutter 3 3
Cardiac Enzyme Elevation 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Perfusion Systems II Sep-22-2021
-
-