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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
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
FREUDENBERG MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC CRYOCATH LP
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 1713 1752
Leak/Splash 865 865
Material Twisted/Bent 274 274
Gas/Air Leak 270 270
Deformation Due to Compressive Stress 111 111
Air/Gas in Device 107 107
Break 92 92
Material Integrity Problem 90 90
Failure to Advance 83 83
Fluid/Blood Leak 75 75
Material Split, Cut or Torn 71 71
Difficult to Insert 68 68
Positioning Failure 67 67
Unintended Movement 63 63
Improper or Incorrect Procedure or Method 61 61
Difficult to Remove 58 58
Compatibility Problem 56 56
Material Deformation 49 49
Difficult or Delayed Positioning 48 48
Device Contamination with Body Fluid 36 36
Difficult to Advance 35 35
Crack 31 31
Noise, Audible 25 25
Peeled/Delaminated 24 24
Material Separation 24 24
Use of Device Problem 22 22
Off-Label Use 21 21
Unstable 20 20
Physical Resistance/Sticking 20 20
Product Quality Problem 18 18
Difficult to Flush 17 17
Device Handling Problem 17 17
Mechanical Problem 13 13
Entrapment of Device 13 13
Device Contamination with Chemical or Other Material 12 12
Detachment of Device or Device Component 9 9
Signal Artifact/Noise 8 8
Tear, Rip or Hole in Device Packaging 8 8
Insufficient Information 7 7
Appropriate Term/Code Not Available 7 7
Mechanical Jam 7 7
Device Markings/Labelling Problem 5 5
Device Damaged by Another Device 5 5
Activation, Positioning or Separation Problem 5 5
Device-Device Incompatibility 4 4
No Apparent Adverse Event 4 4
Mechanics Altered 3 3
Packaging Problem 3 3
Delivered as Unsterile Product 3 3
Loose or Intermittent Connection 3 3
Suction Problem 2 2
Material Perforation 2 2
Material Rupture 2 2
Positioning Problem 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Protrusion/Extrusion 1 1
Infusion or Flow Problem 1 1
Human-Device Interface Problem 1 1
Difficult to Open or Close 1 1
Temperature Problem 1 1
Inaccurate Information 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1
Defective Device 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Unsealed Device Packaging 1 1
Flushing Problem 1 1
Material Frayed 1 1
Loss of or Failure to Bond 1 1
Display or Visual Feedback Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1244 1244
Pericardial Effusion 392 392
Low Blood Pressure/ Hypotension 332 332
Perforation 298 337
Cardiac Tamponade 266 266
No Consequences Or Impact To Patient 261 261
No Known Impact Or Consequence To Patient 236 236
Atrial Perforation 215 215
Hemorrhage/Bleeding 156 156
Thrombosis/Thrombus 152 152
No Patient Involvement 150 150
Air Embolism 149 149
Hematoma 129 129
Cardiac Perforation 104 104
Non specific EKG/ECG Changes 89 89
Thrombosis 84 84
Pseudoaneurysm 72 72
Fistula 66 66
Cardiac Arrest 58 58
Stroke/CVA 52 52
Hypoxia 47 47
Unspecified Tissue Injury 45 45
Arrhythmia 37 37
Death 34 34
Tachycardia 33 33
Perforation of Vessels 32 32
Insufficient Information 32 32
ST Segment Elevation 28 28
Vascular System (Circulation), Impaired 26 26
Embolism 26 26
Cardiovascular Insufficiency 25 25
Chest Pain 24 24
Bradycardia 23 23
Pain 22 22
Tissue Damage 22 22
Dyspnea 21 21
Embolism/Embolus 21 21
Heart Failure/Congestive Heart Failure 20 20
High Blood Pressure/ Hypertension 18 18
Heart Failure 17 17
No Code Available 17 17
Vascular Dissection 15 15
Transient Ischemic Attack 14 14
Respiratory Distress 14 14
Inflammation 13 13
Atrial Flutter 13 13
Ventricular Fibrillation 12 12
Cardiogenic Shock 12 12
Anemia 11 11
Myocardial Infarction 11 11
Paralysis 11 11
Blood Loss 10 10
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Heart Block 10 10
Respiratory Failure 8 8
Foreign Body In Patient 8 8
Atrial Fibrillation 8 8
Pulmonary Embolism 7 7
Paresis 7 7
Nerve Damage 7 7
Loss of consciousness 7 7
Vasoconstriction 7 7
Great Vessel Perforation 6 6
Test Result 6 6
Neurological Deficit/Dysfunction 6 6
Muscle Weakness 5 5
Pleural Effusion 5 5
Intracranial Hemorrhage 5 5
Hemoptysis 5 5
Edema 5 5
Palpitations 5 5
Vomiting 5 5
Shock 5 5
Mitral Valve Insufficiency/ Regurgitation 5 5
Tricuspid Valve Insufficiency/ Regurgitation 5 5
Cough 4 4
Swelling/ Edema 4 4
Exit Block 4 4
Pericarditis 4 4
Sepsis 4 4
Vaso-Vagal Response 4 4
Confusion/ Disorientation 4 4
Fever 4 4
Cardiac Enzyme Elevation 4 4
Headache 4 4
Laceration(s) 4 4
Pulmonary Edema 4 4
Nausea 4 4
Ischemia 3 3
Pneumothorax 3 3
Renal Failure 3 3
Hypersensitivity/Allergic reaction 3 3
Intimal Dissection 3 3
Abdominal Pain 3 3
Aneurysm 3 3
Diminished Pulse Pressure 3 3
Low Oxygen Saturation 3 3
Coma 3 3
Tricuspid Regurgitation 3 3
Weakness 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Mar-26-2024
2 Medtronic Perfusion Systems II Sep-22-2021
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