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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, peripheral, atherectomy
Product CodeMCW
Regulation Number 870.4875
Device Class 2


Premarket Reviews
ManufacturerDecision
AVINGER, INC.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCUALR SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 6
EXIMO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 4
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
REX MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRAUB MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO ATHEROMED INC.
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO ATHEROMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 537 537
2019 618 618
2020 631 753
2021 734 2930
2022 565 565

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 530 774
Entrapment of Device 518 518
Adverse Event Without Identified Device or Use Problem 376 1352
Break 363 973
Material Separation 280 280
Material Deformation 225 347
Mechanical Problem 207 207
Difficult to Remove 190 190
Physical Resistance/Sticking 170 170
Suction Problem 148 148
Fracture 115 115
Device Damaged by Another Device 103 103
Mechanical Jam 97 97
Difficult to Advance 88 88
Noise, Audible 68 68
Use of Device Problem 65 65
Leak/Splash 46 46
Positioning Problem 39 39
Failure to Advance 32 32
Device Markings/Labelling Problem 27 27
Device-Device Incompatibility 26 26
Unexpected Shutdown 25 25
Infusion or Flow Problem 24 24
Material Integrity Problem 24 24
Material Split, Cut or Torn 23 23
Defective Device 23 23
Material Twisted/Bent 22 22
Fluid/Blood Leak 21 21
Retraction Problem 19 19
Peeled/Delaminated 19 19
Aspiration Issue 18 18
Device Operates Differently Than Expected 18 18
Material Puncture/Hole 15 15
Device Difficult to Setup or Prepare 14 14
Deformation Due to Compressive Stress 14 14
Display or Visual Feedback Problem 13 13
Device Remains Activated 13 13
Intermittent Loss of Power 13 13
Unintended System Motion 12 12
Overheating of Device 11 11
Device Contamination with Chemical or Other Material 11 11
Detachment Of Device Component 10 10
Off-Label Use 10 10
Melted 10 10
No Apparent Adverse Event 10 10
Device Displays Incorrect Message 10 10
Insufficient Information 9 9
Difficult to Open or Close 9 9
Device Operational Issue 9 9
Failure to Prime 8 8
Improper or Incorrect Procedure or Method 8 8
Missing Information 8 8
Therapeutic or Diagnostic Output Failure 8 8
Crack 8 252
Difficult or Delayed Activation 8 8
Material Rupture 8 8
Material Perforation 7 7
Activation Problem 7 7
No Flow 7 7
Output Problem 7 7
Compatibility Problem 7 7
Defective Component 6 6
Device Dislodged or Dislocated 6 6
Appropriate Term/Code Not Available 6 6
Difficult to Insert 6 6
Material Frayed 5 5
Obstruction of Flow 5 5
Stretched 5 5
Loss of or Failure to Bond 5 5
Contamination 5 5
Failure to Power Up 5 5
Material Fragmentation 5 5
Device Handling Problem 5 5
Inaccurate Information 5 5
Migration 4 4
Failure to Shut Off 4 4
Activation, Positioning or Separation Problem 4 4
Insufficient Flow or Under Infusion 4 4
Contamination /Decontamination Problem 4 4
Activation Failure 4 4
Connection Problem 3 3
Packaging Problem 3 3
Temperature Problem 3 3
Pumping Stopped 3 3
Failure to Calibrate 3 125
Device Contaminated During Manufacture or Shipping 3 3
Power Problem 3 3
Unintended Movement 3 3
Device Misassembled During Manufacturing /Shipping 2 2
Battery Problem 2 2
Energy Output Problem 2 2
Device Contamination with Body Fluid 2 2
Solder Joint Fracture 2 2
Failure to Infuse 2 2
Tear, Rip or Hole in Device Packaging 2 2
Device Stops Intermittently 2 2
Air/Gas in Device 2 2
Sparking 2 2
Patient-Device Incompatibility 2 2
Material Protrusion/Extrusion 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 958 1568
No Consequences Or Impact To Patient 911 911
Foreign Body In Patient 229 229
No Known Impact Or Consequence To Patient 177 299
Vascular Dissection 139 505
Device Embedded In Tissue or Plaque 117 117
Perforation of Vessels 109 231
Embolism 82 204
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 81 81
Insufficient Information 64 64
Patient Problem/Medical Problem 53 53
Perforation 52 52
Embolism/Embolus 50 294
No Code Available 41 41
Radiation Exposure, Unintended 40 162
Vessel Or Plaque, Device Embedded In 39 39
Injury 37 37
Unintended Radiation Exposure 36 890
Thrombosis/Thrombus 29 29
Pain 28 28
Iatrogenic Source 26 26
Vascular System (Circulation), Impaired 26 26
Obstruction/Occlusion 22 22
Occlusion 20 20
Unspecified Tissue Injury 19 19
Pseudoaneurysm 16 16
Hematoma 16 16
Thrombus 16 16
Reocclusion 15 15
Stenosis 13 13
Myocardial Infarction 12 12
Intimal Dissection 12 12
Death 12 12
Restenosis 10 10
No Patient Involvement 10 10
Rupture 9 9
Hemorrhage/Bleeding 9 9
Thrombosis 9 9
Low Blood Pressure/ Hypotension 8 8
Thromboembolism 8 8
Extravasation 8 8
Aneurysm 7 7
Embolus 7 7
Fistula 7 7
Sepsis 6 6
Ischemia 6 6
Vasoconstriction 4 4
Intraoperative Pain 4 4
Blood Loss 4 4
Peripheral Vascular Disease 4 4
Renal Failure 4 4
Hypersensitivity/Allergic reaction 3 3
Nausea 3 3
Stroke/CVA 3 3
Cardiac Arrest 3 3
Fever 3 3
Calcium Deposits/Calcification 3 3
Deformity/ Disfigurement 2 2
Foreign Body Embolism 2 2
Burning Sensation 2 2
Discomfort 2 2
Tissue Damage 2 2
Swelling/ Edema 2 2
Muscle Spasm(s) 2 2
Dyspnea 2 2
Exsanguination 1 1
Gangrene 1 1
Pulmonary Embolism 1 1
Burn(s) 1 1
Loss of consciousness 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Atrial Perforation 1 1
Skin Tears 1 1
Claudication 1 1
Missing Value Reason 1 1
No Information 1 1
Great Vessel Perforation 1 1
Diminished Pulse Pressure 1 1
Bone Fracture(s) 1 1
Arrhythmia 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Anxiety 1 1
Chest Pain 1 1
Vomiting 1 1
Laceration(s) 1 1
Unspecified Kidney or Urinary Problem 1 1
Unspecified Vascular Problem 1 1
Superficial (First Degree) Burn 1 1
Cardiac Tamponade 1 1
Cardiopulmonary Arrest 1 1
Hyperplasia 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardiovascular Systems Inc II Aug-28-2021
2 Cardiovascular Systems Inc II Oct-11-2018
3 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Sep-11-2018
4 ev3 Inc. I Mar-07-2022
5 ev3 Inc. I Jan-19-2022
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