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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, steerable
Product CodeDRA
Regulation Number 870.1280
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ABBOTT VASCULAR
  SUBSTANTIALLY EQUIVALENT 3
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
CARDIOFOCUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOSOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
EVALVE INC
  SUBSTANTIALLY EQUIVALENT 4
FREUDENBERG MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
GREATBATCH MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
HANSEN MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
HANSEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC CRYOCATH LP
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 212 212
2015 350 350
2016 481 481
2017 625 625
2018 633 633
2019 700 700
2020 703 703
2021 741 778
2022 652 654
2023 787 787
2024 287 287

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2364 2403
Leak/Splash 1143 1143
Air Leak 330 330
Gas/Air Leak 314 314
Material Twisted/Bent 300 300
Fluid/Blood Leak 210 210
Appropriate Term/Code Not Available 205 205
Break 195 195
Material Integrity Problem 128 128
Insufficient Information 120 120
Deformation Due to Compressive Stress 113 113
Failure to Advance 111 111
Air/Gas in Device 107 107
Torn Material 107 107
Difficult to Remove 101 101
Difficult to Insert 101 101
Mechanical Problem 96 96
Improper or Incorrect Procedure or Method 96 96
Device Operates Differently Than Expected 92 92
Material Split, Cut or Torn 77 77
Kinked 76 76
Unintended Movement 73 73
Positioning Failure 72 72
Material Deformation 66 66
Compatibility Problem 56 56
Difficult or Delayed Positioning 56 56
Detachment Of Device Component 50 50
Unstable 49 49
Difficult to Advance 40 40
Crack 39 39
Device Contamination with Body Fluid 37 37
Loose or Intermittent Connection 31 31
Noise, Audible 29 29
Material Separation 27 27
Physical Resistance 27 27
Device Contamination with Chemical or Other Material 26 26
Peeled/Delaminated 25 25
Use of Device Problem 22 22
Off-Label Use 21 21
Physical Resistance/Sticking 20 20
Difficult To Position 19 19
Product Quality Problem 18 18
Difficult to Flush 17 17
Device Handling Problem 17 17
Entrapment of Device 15 15
Loss of or Failure to Bond 12 12
Detachment of Device or Device Component 11 11
Device Damaged by Another Device 10 10
Device Slipped 10 10
Tear, Rip or Hole in Device Packaging 9 9
Aspiration Issue 9 9
Activation, Positioning or Separation Problem 8 8
Signal Artifact/Noise 8 8
Delivered as Unsterile Product 8 8
No Apparent Adverse Event 8 8
Physical Property Issue 8 8
Mechanical Jam 7 7
Bent 7 7
Suction Problem 5 5
Device Markings/Labelling Problem 5 5
Positioning Problem 5 5
Device-Device Incompatibility 4 4
Disconnection 4 4
Device Expiration Issue 3 3
Device Displays Incorrect Message 3 3
Packaging Problem 3 3
Human-Device Interface Problem 3 3
Device Dislodged or Dislocated 3 3
Mechanics Altered 3 3
Device Contaminated During Manufacture or Shipping 2 2
Difficult to Open or Close 2 2
Temperature Problem 2 2
Material Rupture 2 2
Defective Device 2 2
Material Perforation 2 2
Unsealed Device Packaging 2 2
Material Frayed 2 2
Inflation Problem 1 1
Flushing Problem 1 1
Display or Visual Feedback Problem 1 1
Problem with Removal of Enzymatic Cleaner 1 1
Contamination 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Deflation Problem 1 1
Device Appears to Trigger Rejection 1 1
Loss of Power 1 1
Device Difficult to Setup or Prepare 1 1
Occlusion Within Device 1 1
Migration or Expulsion of Device 1 1
Nonstandard Device 1 1
Defective Component 1 1
Out-Of-Box Failure 1 1
Obstruction of Flow 1 1
Incorrect Or Inadequate Test Results 1 1
Structural Problem 1 1
Sticking 1 1
Defibrillation/Stimulation Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1
Material Too Rigid or Stiff 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1244 1244
No Known Impact Or Consequence To Patient 769 769
No Consequences Or Impact To Patient 649 649
Pericardial Effusion 591 591
Low Blood Pressure/ Hypotension 517 517
Cardiac Tamponade 439 439
Atrial Perforation 364 364
No Patient Involvement 362 362
Perforation 337 376
Air Embolism 239 239
Hemorrhage/Bleeding 235 235
Hematoma 228 229
Thrombosis 174 174
Pseudoaneurysm 158 158
Thrombosis/Thrombus 152 152
Cardiac Perforation 149 149
ST Segment Elevation 137 137
Fistula 112 113
Cardiac Arrest 100 101
Non specific EKG/ECG Changes 96 96
Death 78 78
Stroke/CVA 64 64
Hypoxia 50 50
Arrhythmia 47 47
Bradycardia 45 45
Tissue Damage 45 45
Unspecified Tissue Injury 45 45
Vascular System (Circulation), Impaired 44 44
No Code Available 44 44
Embolism 43 43
Chest Pain 41 41
Pain 41 41
Blood Loss 39 40
Perforation of Vessels 36 36
Tachycardia 35 35
Insufficient Information 32 32
Dyspnea 30 30
Cardiovascular Insufficiency 25 25
High Blood Pressure/ Hypertension 23 23
Ventricular Fibrillation 23 23
Heart Failure 23 23
Embolism/Embolus 21 21
Heart Failure/Congestive Heart Failure 20 20
Vascular Dissection 20 20
Anemia 20 20
Paralysis 19 19
Respiratory Distress 19 19
Transient Ischemic Attack 18 18
Myocardial Infarction 18 18
Inflammation 17 17
Atrial Flutter 15 15
Neurological Deficit/Dysfunction 15 15
Cardiogenic Shock 15 15
Loss of consciousness 12 12
Pleural Effusion 12 12
Test Result 12 12
Respiratory Failure 12 12
Paresis 11 11
Nerve Damage 11 11
Fever 10 10
Atrial Fibrillation 10 10
Vasoconstriction 10 10
Foreign Body In Patient 10 10
Vaso-Vagal Response 10 10
Heart Block 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Ventricular Tachycardia 9 9
Pneumothorax 9 9
Great Vessel Perforation 9 9
Edema 9 9
Pulmonary Embolism 8 8
Hemoptysis 8 8
Dizziness 8 8
Exit Block 8 8
Shock 7 7
Laceration(s) 7 7
Cardiopulmonary Arrest 7 7
Infarction, Cerebral 6 6
Sepsis 6 6
Thrombus 6 6
Vomiting 6 6
Confusion/ Disorientation 6 6
Mitral Valve Insufficiency/ Regurgitation 5 5
Tricuspid Valve Insufficiency/ Regurgitation 5 5
Palpitations 5 5
Numbness 5 5
Visual Disturbances 5 5
Occlusion 5 5
Intimal Dissection 5 5
Aneurysm 5 5
Muscle Weakness 5 5
Nausea 5 5
Mitral Regurgitation 5 5
Unspecified Infection 5 5
Intracranial Hemorrhage 5 5
Hemothorax 5 5
Headache 4 4
Cardiac Enzyme Elevation 4 4
Muscle Spasm(s) 4 4
Ischemia 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Mar-26-2024
2 Greatbatch Medical II Sep-26-2012
3 Medtronic Inc. Cardiac Rhythm Disease Management II Sep-12-2011
4 Medtronic Perfusion Systems II Sep-22-2021
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