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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
2023 59 59

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1868 1907
Leak/Splash 814 814
Gas/Air Leak 276 276
Air Leak 251 251
Material Twisted/Bent 234 234
Appropriate Term/Code Not Available 200 200
Fluid/Blood Leak 183 183
Break 149 149
Material Integrity Problem 101 101
Failure to Advance 87 87
Deformation Due to Compressive Stress 86 86
Mechanical Problem 82 82
Kinked 73 73
Difficult to Remove 73 73
Improper or Incorrect Procedure or Method 71 71
Device Operates Differently Than Expected 62 62
Difficult to Insert 61 61
Material Split, Cut or Torn 58 58
Unintended Movement 58 58
Positioning Failure 54 54
Torn Material 51 51
Difficult or Delayed Positioning 48 48
Material Deformation 42 42
Unstable 35 35
Difficult to Advance 27 27
Loose or Intermittent Connection 27 27
Crack 27 27
Noise, Audible 25 25
Device Contamination with Body Fluid 25 25
Material Separation 24 24
Detachment Of Device Component 23 23
Device Contamination with Chemical or Other Material 19 19
Off-Label Use 17 17
Insufficient Information 17 17
Compatibility Problem 15 15
Physical Resistance/Sticking 15 15
Physical Resistance 14 14
Difficult to Flush 13 13
Peeled/Delaminated 12 12
Product Quality Problem 11 11
Difficult To Position 11 11
Air/Gas in Device 10 10
Device Handling Problem 9 9
Entrapment of Device 9 9
Delivered as Unsterile Product 8 8
Use of Device Problem 8 8
No Apparent Adverse Event 7 7
Physical Property Issue 7 7
Tear, Rip or Hole in Device Packaging 7 7
Mechanical Jam 6 6
Device Damaged by Another Device 6 6
Device Markings/Labelling Problem 5 5
Activation, Positioning or Separation Problem 4 4
Bent 4 4
Aspiration Issue 4 4
Device Slipped 3 3
Signal Artifact/Noise 3 3
Loss of or Failure to Bond 2 2
Defective Device 2 2
Suction Problem 2 2
Detachment of Device or Device Component 2 2
Difficult to Open or Close 2 2
Packaging Problem 2 2
Material Rupture 2 2
Incomplete Coaptation 1 1
Failure to Disconnect 1 1
Contamination /Decontamination Problem 1 1
Connection Problem 1 1
Material Frayed 1 1
Mechanics Altered 1 1
Positioning Problem 1 1
Naturally Worn 1 1
Temperature Problem 1 1
Structural Problem 1 1
Incorrect, Inadequate or Imprecise Result or Readings 1 1
Retraction Problem 1 1
Nonstandard Device 1 1
Display or Visual Feedback Problem 1 1
Device Expiration Issue 1 1
Device-Device Incompatibility 1 1
Device Contaminated During Manufacture or Shipping 1 1
Application Interface Becomes Non-Functional Or Program Exits Abnormally 1 1
Sticking 1 1
Unsealed Device Packaging 1 1
Out-Of-Box Failure 1 1
Human-Device Interface Problem 1 1
Material Protrusion/Extrusion 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 698 698
No Known Impact Or Consequence To Patient 662 662
No Consequences Or Impact To Patient 508 508
Pericardial Effusion 448 448
Low Blood Pressure/ Hypotension 388 388
Atrial Perforation 333 333
Cardiac Tamponade 331 331
No Patient Involvement 319 319
Perforation 229 268
Hematoma 186 187
Air Embolism 177 177
Hemorrhage/Bleeding 161 161
Thrombosis 154 154
Pseudoaneurysm 128 128
Cardiac Perforation 124 124
ST Segment Elevation 114 114
Thrombosis/Thrombus 96 96
Fistula 88 89
Cardiac Arrest 75 75
Death 70 70
Non specific EKG/ECG Changes 58 58
Stroke/CVA 46 46
Vascular System (Circulation), Impaired 43 43
Embolism 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
Unspecified Tissue Injury 29 29
Hypoxia 27 27
Insufficient Information 27 27
Tachycardia 25 25
Perforation of Vessels 24 24
Heart Failure 23 23
Dyspnea 23 23
Ventricular Fibrillation 20 20
Respiratory Distress 18 18
High Blood Pressure/ Hypertension 18 18
Myocardial Infarction 17 17
Paralysis 16 16
Anemia 15 15
Embolism/Embolus 14 14
Inflammation 13 13
Neurological Deficit/Dysfunction 13 13
Cardiovascular Insufficiency 13 13
Loss of consciousness 12 12
Vascular Dissection 11 11
Heart Failure/Congestive Heart Failure 11 11
Test Result 10 10
Cardiogenic Shock 9 9
Respiratory Failure 9 9
Vaso-Vagal Response 9 9
Paresis 9 9
Ventricular Tachycardia 8 8
Atrial Flutter 8 8
Edema 8 8
Vasoconstriction 8 8
Exit Block 8 8
Fever 8 8
Cardiopulmonary Arrest 7 7
Dizziness 7 7
Pleural Effusion 7 7
Pneumothorax 7 7
Hemoptysis 7 7
Shock 7 7
Great Vessel Perforation 7 7
Heart Block 6 6
Pulmonary Embolism 6 6
Transient Ischemic Attack 6 6
Nerve Damage 6 6
Atrial Fibrillation 5 5
Vomiting 5 5
Muscle Weakness 5 5
Thrombus 5 5
Palpitations 5 5
Infarction, Cerebral 5 5
Intimal Dissection 5 5
Bacterial Infection 4 4
Cardiac Enzyme Elevation 4 4
Nausea 4 4
Confusion/ Disorientation 4 4
Mitral Regurgitation 4 4
Intracranial Hemorrhage 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Visual Disturbances 4 4
Pericarditis 4 4
Weakness 4 4
Tricuspid Regurgitation 4 4
Headache 4 4
Unspecified Infection 4 4
Pneumonia 4 4
Tricuspid Valve Insufficiency/ Regurgitation 4 4
Mitral Valve Insufficiency/ Regurgitation 3 3
Laceration(s) 3 3
Hemothorax 3 3
Seizures 3 3
Stenosis 3 3

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