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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
CARDIO FLOW INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIO FLOW, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCUALR SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 4
EXIMO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 4
EXIMO MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
REX MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO ATHEROMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 618 618
2020 631 753
2021 734 2930
2022 566 566
2023 575 575
2024 208 208

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 587 831
Break 570 1180
Entrapment of Device 505 505
Adverse Event Without Identified Device or Use Problem 470 1446
Material Separation 277 277
Material Deformation 249 371
Physical Resistance/Sticking 211 211
Difficult to Remove 209 209
Mechanical Problem 195 195
Mechanical Jam 163 163
Suction Problem 150 150
Fracture 111 111
Difficult to Advance 88 88
Device Damaged by Another Device 84 84
Noise, Audible 71 71
Use of Device Problem 63 63
Leak/Splash 61 61
Retraction Problem 45 45
Failure to Advance 42 42
Positioning Problem 38 38
Device Markings/Labelling Problem 28 28
Device-Device Incompatibility 25 25
Defective Device 25 25
Fluid/Blood Leak 24 24
Material Integrity Problem 23 23
Material Split, Cut or Torn 23 23
Unexpected Shutdown 23 23
Infusion or Flow Problem 20 20
Overheating of Device 20 20
Peeled/Delaminated 16 16
Deformation Due to Compressive Stress 15 15
Intermittent Loss of Power 15 15
Material Puncture/Hole 14 14
Off-Label Use 14 14
Device Difficult to Setup or Prepare 14 14
Melted 13 13
Material Twisted/Bent 13 13
No Apparent Adverse Event 12 12
Display or Visual Feedback Problem 11 11
Stretched 11 11
Unintended System Motion 10 10
Difficult or Delayed Activation 10 10
Activation Problem 10 10
Insufficient Information 9 9
Device Displays Incorrect Message 9 9
Device Contamination with Chemical or Other Material 9 9
Failure to Prime 9 9
Contamination 8 8
Compatibility Problem 8 8
Device Remains Activated 8 8
Improper or Incorrect Procedure or Method 8 8
Output Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
Missing Information 8 8
Air/Gas in Device 7 7
No Flow 7 7
Crack 7 251
Difficult to Insert 6 6
Difficult to Open or Close 6 6
Material Perforation 6 6
Inaccurate Information 6 6
Unintended Movement 6 6
Device Handling Problem 6 6
Migration 5 5
Defective Component 5 5
Device Dislodged or Dislocated 5 5
Connection Problem 5 5
Material Rupture 5 5
Loss of or Failure to Bond 4 4
Material Fragmentation 4 4
Activation, Positioning or Separation Problem 4 4
Insufficient Flow or Under Infusion 4 4
Device Contamination with Body Fluid 4 4
Obstruction of Flow 4 4
Appropriate Term/Code Not Available 4 4
Sharp Edges 4 4
Temperature Problem 3 3
Wrong Label 3 3
Activation Failure 3 3
Packaging Problem 3 3
Power Problem 3 3
Failure to Calibrate 3 125
Contamination /Decontamination Problem 3 3
Failure to Shut Off 3 3
Device Contaminated During Manufacture or Shipping 3 3
Material Frayed 3 3
Flushing Problem 3 3
Complete Blockage 3 3
Pumping Stopped 3 3
Delivered as Unsterile Product 2 2
Energy Output Problem 2 2
Component Incompatible 2 2
Degraded 2 2
Flaked 2 2
Difficult to Flush 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Malposition of Device 2 2
Patient-Device Incompatibility 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Structural Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1474 2084
No Consequences Or Impact To Patient 623 623
Foreign Body In Patient 230 230
Vascular Dissection 159 525
Perforation of Vessels 133 255
Embolism/Embolus 127 371
No Known Impact Or Consequence To Patient 123 245
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 115 115
Device Embedded In Tissue or Plaque 111 111
Insufficient Information 72 72
Perforation 64 64
Embolism 58 180
Unintended Radiation Exposure 50 904
Thrombosis/Thrombus 44 44
Pain 35 35
Patient Problem/Medical Problem 32 32
Radiation Exposure, Unintended 32 154
Vessel Or Plaque, Device Embedded In 31 31
Injury 28 28
Obstruction/Occlusion 28 28
Vascular System (Circulation), Impaired 25 25
No Code Available 25 25
Stenosis 24 24
Iatrogenic Source 23 23
Pseudoaneurysm 19 19
Hematoma 19 19
Unspecified Tissue Injury 19 19
Restenosis 16 16
Aneurysm 15 15
Occlusion 14 14
Myocardial Infarction 14 14
Hemorrhage/Bleeding 13 13
Extravasation 10 10
Thromboembolism 10 10
Rupture 9 9
Ischemia 9 9
Reocclusion 9 9
Fistula 8 8
Low Blood Pressure/ Hypotension 8 8
Thrombus 8 8
Vasoconstriction 8 8
Thrombosis 7 7
Death 7 7
Intimal Dissection 7 7
Renal Failure 6 6
Sepsis 6 6
Cardiac Arrest 5 5
Swelling/ Edema 5 5
Foreign Body Embolism 4 4
Embolus 4 4
Intraoperative Pain 4 4
No Patient Involvement 4 4
Blood Loss 3 3
Fever 3 3
Stroke/CVA 3 3
Hypersensitivity/Allergic reaction 3 3
Nausea 3 3
Muscle Spasm(s) 2 2
Chest Pain 2 2
Arrhythmia 2 2
Calcium Deposits/Calcification 2 2
Ecchymosis 2 2
Discomfort 2 2
Tissue Damage 2 2
Burning Sensation 2 2
Great Vessel Perforation 1 1
Vomiting 1 1
Cardiac Tamponade 1 1
Anxiety 1 1
Tachycardia 1 1
Peripheral Vascular Disease 1 1
Diminished Pulse Pressure 1 1
Skin Tears 1 1
Claudication 1 1
Respiratory Failure 1 1
Loss of consciousness 1 1
Dyspnea 1 1
Exsanguination 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Pulmonary Embolism 1 1
Laceration(s) 1 1
High Blood Pressure/ Hypertension 1 1
Unspecified Infection 1 1
Bone Fracture(s) 1 1
Hyperplasia 1 1
Missing Value Reason 1 1
Arteriosclerosis/ Atherosclerosis 1 1
No Information 1 1
Unspecified Vascular Problem 1 1
Respiratory Arrest 1 1
Unspecified Kidney or Urinary Problem 1 1
Localized Skin Lesion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardiovascular Systems Inc II Aug-28-2021
2 Spectranetics Corporation II Dec-08-2023
3 ev3 Inc. I Mar-07-2022
4 ev3 Inc. I Jan-19-2022
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