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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 423 423

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 2407 2446
Leak/Splash 1177 1177
Air Leak 330 330
Gas/Air Leak 323 323
Material Twisted/Bent 303 303
Fluid/Blood Leak 210 210
Appropriate Term/Code Not Available 206 206
Break 196 196
Air/Gas in Device 149 149
Material Integrity Problem 132 132
Insufficient Information 120 120
Deformation Due to Compressive Stress 115 115
Failure to Advance 111 111
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 79 79
Kinked 76 76
Unintended Movement 75 75
Positioning Failure 74 74
Material Deformation 66 66
Compatibility Problem 59 59
Difficult or Delayed Positioning 57 57
Detachment Of Device Component 50 50
Unstable 49 49
Difficult to Advance 41 41
Device Contamination with Body Fluid 39 39
Crack 39 39
Loose or Intermittent Connection 31 31
Noise, Audible 29 29
Material Separation 28 28
Physical Resistance 27 27
Device Contamination with Chemical or Other Material 27 27
Peeled/Delaminated 25 25
Use of Device Problem 23 23
Off-Label Use 21 21
Physical Resistance/Sticking 21 21
Difficult To Position 19 19
Product Quality Problem 18 18
Device Handling Problem 18 18
Difficult to Flush 17 17
Entrapment of Device 15 15
Loss of or Failure to Bond 12 12
Detachment of Device or Device Component 12 12
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
Device-Device Incompatibility 5 5
Suction Problem 5 5
Device Markings/Labelling Problem 5 5
Positioning Problem 5 5
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 1331 1331
No Known Impact Or Consequence To Patient 769 769
No Consequences Or Impact To Patient 649 649
Pericardial Effusion 597 597
Low Blood Pressure/ Hypotension 524 524
Cardiac Tamponade 445 445
Atrial Perforation 364 364
No Patient Involvement 362 362
Perforation 340 379
Air Embolism 244 244
Hemorrhage/Bleeding 238 238
Hematoma 230 231
Thrombosis 174 174
Pseudoaneurysm 159 159
Thrombosis/Thrombus 159 159
Cardiac Perforation 153 153
ST Segment Elevation 137 137
Fistula 118 119
Cardiac Arrest 101 102
Non specific EKG/ECG Changes 101 101
Death 78 78
Stroke/CVA 71 71
Hypoxia 52 52
Arrhythmia 49 49
Unspecified Tissue Injury 48 48
Bradycardia 46 46
Tissue Damage 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 37 37
Tachycardia 35 35
Insufficient Information 34 34
Dyspnea 30 30
Cardiovascular Insufficiency 28 28
Ventricular Fibrillation 24 24
Heart Failure 23 23
High Blood Pressure/ Hypertension 23 23
Embolism/Embolus 21 21
Heart Failure/Congestive Heart Failure 20 20
Vascular Dissection 20 20
Myocardial Infarction 20 20
Anemia 20 20
Paralysis 20 20
Respiratory Distress 19 19
Transient Ischemic Attack 18 18
Inflammation 17 17
Atrial Flutter 15 15
Neurological Deficit/Dysfunction 15 15
Cardiogenic Shock 15 15
Loss of consciousness 12 12
Paresis 12 12
Pleural Effusion 12 12
Test Result 12 12
Respiratory Failure 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 12
Nerve Damage 11 11
Atrial Fibrillation 11 11
Fever 11 11
Vasoconstriction 10 10
Dizziness 10 10
Heart Block 10 10
Foreign Body In Patient 10 10
Vaso-Vagal Response 10 10
Great Vessel Perforation 9 9
Ventricular Tachycardia 9 9
Pneumothorax 9 9
Edema 9 9
Pulmonary Embolism 8 8
Hemoptysis 8 8
Exit Block 8 8
Cardiopulmonary Arrest 7 7
Laceration(s) 7 7
Shock 7 7
Sepsis 6 6
Thrombus 6 6
Vomiting 6 6
Infarction, Cerebral 6 6
Confusion/ Disorientation 6 6
Mitral Valve Insufficiency/ Regurgitation 5 5
Tricuspid Valve Insufficiency/ Regurgitation 5 5
Intimal Dissection 5 5
Bacterial Infection 5 5
Aneurysm 5 5
Mitral Regurgitation 5 5
Nausea 5 5
Muscle Weakness 5 5
Unspecified Infection 5 5
Intracranial Hemorrhage 5 5
Hemothorax 5 5
Visual Disturbances 5 5
Numbness 5 5
Palpitations 5 5
Occlusion 5 5
Pneumonia 4 4
Pulmonary Edema 4 4
Swelling 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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