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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, steerable
Regulation Description Steerable catheter.
Product CodeDRA
Regulation Number 870.1280
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
  1.  K161985  Steerable Guide Catheter
  2.  K172394  Steerable Guide Catheter
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 2
  1.  K161985  Steerable Guide Catheter
  2.  K172394  Steerable Guide Catheter
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 740 742

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1543 1545
Leak/Splash 633 633
Air Leak 251 251
Gas Leak 244 244
Appropriate Term/Code Not Available 199 199
Material Twisted/Bent 196 196
Fluid Leak 181 181
Break 133 133
Material Integrity Problem 93 93
Mechanical Problem 80 80
Kinked 73 73
Failure to Advance 70 70
Improper or Incorrect Procedure or Method 64 64
Deformation Due to Compressive Stress 63 63
Device Operates Differently Than Expected 62 62
Difficult to Remove 60 60
Torn Material 51 51
Difficult to Insert 49 49
Positioning Failure 46 46
Unintended Movement 46 46
Material Split, Cut or Torn 46 46
Difficult or Delayed Positioning 31 31
Unstable 31 31
Loose or Intermittent Connection 27 27
Material Deformation 24 24
Detachment Of Device Component 23 23
Material Separation 22 22
Difficult to Advance 22 22
Device Contamination with Body Fluid 21 21
Noise, Audible 19 19
Device Contamination with Chemical or Other Material 16 16
Crack 16 16
Off-Label Use 15 15
Insufficient Information 15 15
Physical Resistance 14 14
Difficult To Position 11 11
Difficult to Flush 10 10
Physical Resistance/Sticking 10 10
Product Quality Problem 8 8
Delivered as Unsterile Product 7 7
Physical Property Issue 7 7
Device Damaged by Another Device 6 6
Device Markings/Labelling Problem 5 5
Tear, Rip or Hole in Device Packaging 5 5
Mechanical Jam 5 5
No Apparent Adverse Event 5 5
Entrapment of Device 5 5
Bent 4 4
Compatibility Problem 4 4
Aspiration Issue 4 4
Activation, Positioning or SeparationProblem 3 3
Device Slipped 3 3
Peeled/Delaminated 2 2
Signal Artifact/Noise 2 2
Suction Problem 2 2
Difficult to Open or Close 2 2
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
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
Inaccurate Information 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 368 368
No Clinical Signs, Symptoms or Conditions 362 362
Atrial Perforation 333 333
No Patient Involvement 319 319
Low Blood Pressure/ Hypotension 314 314
Cardiac Tamponade 273 273
Hematoma 166 167
Thrombosis 154 154
Perforation 141 143
Air Embolism 140 140
Hemorrhage/Bleeding 128 128
ST Segment Elevation 114 114
Pseudoaneurysm 114 114
Cardiac Perforation 101 101
Fistula 82 83
Death 70 70
Cardiac Arrest 63 63
Embolism 43 43
Vascular System (Circulation), Impaired 43 43
Tissue Damage 41 41
Non specific EKG/ECG Changes 40 40
Thrombosis/Thrombus 40 40
No Code Available 39 39
Stroke/CVA 35 35
Arrhythmia 34 34
Blood Loss 32 32
Bradycardia 30 30
Pain 29 29
Chest Pain 28 28
Insufficient Information 26 26
Heart Failure 23 23
Dyspnea 20 20
Respiratory Distress 18 18
Ventricular Fibrillation 17 17
Paralysis 16 16
High Blood Pressure/ Hypertension 15 15
Hypoxia 14 14
Myocardial Infarction 14 14
Anemia 14 14
Neurological Deficit/Dysfunction 13 13
Loss of consciousness 12 12
Inflammation 11 11
Unspecified Tissue Injury 11 11
Test Result 10 10
Perforation of Vessels 10 10
Tachycardia 9 9
Vaso-Vagal Response 9 9
Respiratory Failure 9 9
Exit Block 8 8
Ventricular Tachycardia 8 8
Fever 8 8
Paresis 8 8
Edema 8 8
Embolism/Embolus 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
Atrial Flutter 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
Pericarditis 4 4
Cardiovascular Insufficiency 4 4
Tricuspid Valve Insufficiency/ Regurgitation 3 3
Patient Problem/Medical Problem 3 3
Visual Disturbances 3 3
Stenosis 3 3
Brain Injury 3 3
Seizures 3 3
Sepsis 3 3
Swelling 3 3
Complete Heart Block 3 3
Numbness 3 3
Coma 3 3
Ischemia 3 3
Hemothorax 3 3

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