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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 2
ACUTUS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
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 741 778
2022 654 656

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1838 1877
Leak/Splash 797 797
Gas/Air Leak 275 275
Air Leak 251 251
Material Twisted/Bent 233 233
Appropriate Term/Code Not Available 200 200
Fluid/Blood Leak 183 183
Break 148 148
Material Integrity Problem 100 100
Failure to Advance 87 87
Deformation Due to Compressive Stress 85 85
Mechanical Problem 81 81
Kinked 73 73
Difficult to Remove 71 71
Improper or Incorrect Procedure or Method 70 70
Device Operates Differently Than Expected 62 62
Difficult to Insert 61 61
Unintended Movement 57 57
Material Split, Cut or Torn 57 57
Positioning Failure 54 54
Torn Material 51 51
Difficult or Delayed Positioning 46 46
Material Deformation 41 41
Unstable 33 33
Difficult to Advance 27 27
Loose or Intermittent Connection 27 27
Crack 26 26
Material Separation 24 24
Device Contamination with Body Fluid 24 24
Noise, Audible 24 24
Detachment Of Device Component 23 23
Device Contamination with Chemical or Other Material 19 19
Off-Label Use 17 17
Insufficient Information 16 16
Physical Resistance/Sticking 15 15
Physical Resistance 14 14
Compatibility Problem 13 13
Difficult to Flush 13 13
Peeled/Delaminated 12 12
Difficult To Position 11 11
Product Quality Problem 10 10
Air/Gas in Device 10 10
Entrapment of Device 9 9
Delivered as Unsterile Product 8 8
Use of Device Problem 8 8
Tear, Rip or Hole in Device Packaging 7 7
Device Handling Problem 7 7
Physical Property Issue 7 7
No Apparent Adverse Event 6 6
Mechanical Jam 6 6
Device Damaged by Another Device 6 6
Device Markings/Labelling Problem 5 5
Aspiration Issue 4 4
Activation, Positioning or Separation Problem 4 4
Bent 4 4
Signal Artifact/Noise 3 3
Device Slipped 3 3
Material Rupture 2 2
Loss of or Failure to Bond 2 2
Detachment of Device or Device Component 2 2
Defective Device 2 2
Suction Problem 2 2
Difficult to Open or Close 2 2
Packaging Problem 2 2
Material Protrusion/Extrusion 1 1
Positioning Problem 1 1
Temperature Problem 1 1
Inaccurate Information 1 1
Human-Device Interface Problem 1 1
Device-Device Incompatibility 1 1
Mechanics Altered 1 1
Naturally Worn 1 1
Device Contaminated During Manufacture or Shipping 1 1
Out-Of-Box Failure 1 1
Structural Problem 1 1
Incomplete Coaptation 1 1
Failure to Disconnect 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Device Expiration Issue 1 1
Display or Visual Feedback Problem 1 1
Material Frayed 1 1
Sticking 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1
Unsealed Device Packaging 1 1
Nonstandard Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 670 670
No Known Impact Or Consequence To Patient 662 662
No Consequences Or Impact To Patient 508 508
Pericardial Effusion 441 441
Low Blood Pressure/ Hypotension 381 381
Atrial Perforation 333 333
Cardiac Tamponade 324 324
No Patient Involvement 319 319
Perforation 218 257
Hematoma 185 186
Air Embolism 177 177
Hemorrhage/Bleeding 158 158
Thrombosis 154 154
Pseudoaneurysm 127 127
Cardiac Perforation 123 123
ST Segment Elevation 114 114
Thrombosis/Thrombus 95 95
Fistula 87 88
Cardiac Arrest 74 74
Death 70 70
Non specific EKG/ECG Changes 57 57
Stroke/CVA 45 45
Embolism 43 43
Vascular System (Circulation), Impaired 43 43
Tissue Damage 41 41
Arrhythmia 39 39
No Code Available 39 39
Bradycardia 36 36
Pain 32 32
Blood Loss 32 32
Chest Pain 31 31
Insufficient Information 27 27
Unspecified Tissue Injury 26 26
Hypoxia 25 25
Tachycardia 24 24
Perforation of Vessels 23 23
Heart Failure 23 23
Dyspnea 22 22
Ventricular Fibrillation 20 20
Respiratory Distress 18 18
High Blood Pressure/ Hypertension 17 17
Myocardial Infarction 17 17
Paralysis 16 16
Anemia 15 15
Neurological Deficit/Dysfunction 13 13
Inflammation 13 13
Cardiovascular Insufficiency 13 13
Embolism/Embolus 13 13
Loss of consciousness 12 12
Heart Failure/Congestive Heart Failure 11 11
Vascular Dissection 11 11
Test Result 10 10
Respiratory Failure 9 9
Vaso-Vagal Response 9 9
Cardiogenic Shock 9 9
Paresis 9 9
Fever 8 8
Atrial Flutter 8 8
Edema 8 8
Ventricular Tachycardia 8 8
Vasoconstriction 8 8
Exit Block 8 8
Great Vessel Perforation 7 7
Dizziness 7 7
Shock 7 7
Pneumothorax 7 7
Cardiopulmonary Arrest 7 7
Hemoptysis 7 7
Pleural Effusion 6 6
Nerve Damage 6 6
Pulmonary Embolism 6 6
Heart Block 6 6
Intimal Dissection 5 5
Infarction, Cerebral 5 5
Muscle Weakness 5 5
Thrombus 5 5
Transient Ischemic Attack 5 5
Vomiting 5 5
Palpitations 5 5
Confusion/ Disorientation 4 4
Weakness 4 4
Visual Disturbances 4 4
Tricuspid Regurgitation 4 4
Nausea 4 4
Mitral Regurgitation 4 4
Unspecified Infection 4 4
Pneumonia 4 4
Headache 4 4
Intracranial Hemorrhage 4 4
Cardiac Enzyme Elevation 4 4
Atrial Fibrillation 4 4
Tricuspid Valve Insufficiency/ Regurgitation 4 4
Pericarditis 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Mitral Valve Insufficiency/ Regurgitation 3 3
Speech Disorder 3 3
Bacterial Infection 3 3
Aneurysm 3 3
Hemothorax 3 3
Ischemia 3 3

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