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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 145 145

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 574 818
Break 552 1162
Entrapment of Device 502 502
Adverse Event Without Identified Device or Use Problem 445 1421
Material Separation 275 275
Material Deformation 242 364
Physical Resistance/Sticking 209 209
Difficult to Remove 205 205
Mechanical Problem 194 194
Mechanical Jam 159 159
Suction Problem 149 149
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 59 59
Retraction Problem 44 44
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
Intermittent Loss of Power 15 15
Device Difficult to Setup or Prepare 14 14
Off-Label Use 14 14
Material Puncture/Hole 13 13
Melted 13 13
Material Twisted/Bent 13 13
Deformation Due to Compressive Stress 13 13
No Apparent Adverse Event 12 12
Display or Visual Feedback Problem 11 11
Stretched 10 10
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
Device Remains Activated 8 8
Contamination 8 8
Compatibility Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8
Output Problem 8 8
Missing Information 8 8
No Flow 7 7
Improper or Incorrect Procedure or Method 7 7
Crack 7 251
Difficult to Insert 6 6
Material Perforation 6 6
Difficult to Open or Close 6 6
Unintended Movement 6 6
Device Handling Problem 6 6
Air/Gas in Device 6 6
Inaccurate Information 6 6
Migration 5 5
Device Dislodged or Dislocated 5 5
Connection Problem 5 5
Defective Component 5 5
Material Rupture 5 5
Material Fragmentation 4 4
Loss of or Failure to Bond 4 4
Obstruction of Flow 4 4
Device Contamination with Body Fluid 4 4
Insufficient Flow or Under Infusion 4 4
Activation, Positioning or Separation Problem 4 4
Appropriate Term/Code Not Available 4 4
Sharp Edges 4 4
Wrong Label 3 3
Temperature Problem 3 3
Activation Failure 3 3
Failure to Shut Off 3 3
Device Contaminated During Manufacture or Shipping 3 3
Power Problem 3 3
Failure to Calibrate 3 125
Contamination /Decontamination Problem 3 3
Complete Blockage 3 3
Material Frayed 3 3
Pumping Stopped 3 3
Energy Output Problem 2 2
Flaked 2 2
Difficult to Flush 2 2
Flushing Problem 2 2
Component Incompatible 2 2
Degraded 2 2
Malposition of Device 2 2
Patient-Device Incompatibility 2 2
Calibration Problem 2 2
Sparking 2 2
Misfire 2 2
Structural Problem 2 2
Solder Joint Fracture 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1437 2047
No Consequences Or Impact To Patient 623 623
Foreign Body In Patient 229 229
Vascular Dissection 150 516
Perforation of Vessels 132 254
No Known Impact Or Consequence To Patient 123 245
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 114 114
Embolism/Embolus 113 357
Device Embedded In Tissue or Plaque 111 111
Insufficient Information 72 72
Perforation 61 61
Embolism 58 180
Unintended Radiation Exposure 49 903
Thrombosis/Thrombus 41 41
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 26 26
Vascular System (Circulation), Impaired 25 25
No Code Available 25 25
Iatrogenic Source 23 23
Pseudoaneurysm 19 19
Unspecified Tissue Injury 19 19
Restenosis 16 16
Hematoma 16 16
Aneurysm 15 15
Occlusion 14 14
Stenosis 14 14
Myocardial Infarction 13 13
Hemorrhage/Bleeding 12 12
Extravasation 10 10
Reocclusion 9 9
Rupture 9 9
Thromboembolism 9 9
Thrombus 8 8
Ischemia 8 8
Fistula 8 8
Low Blood Pressure/ Hypotension 8 8
Death 7 7
Intimal Dissection 7 7
Thrombosis 7 7
Vasoconstriction 6 6
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
Hypersensitivity/Allergic reaction 3 3
Nausea 3 3
Muscle Spasm(s) 2 2
Calcium Deposits/Calcification 2 2
Ecchymosis 2 2
Stroke/CVA 2 2
Chest Pain 2 2
Arrhythmia 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
Bradycardia 1 1
Bruise/Contusion 1 1
Pulmonary Embolism 1 1
Dyspnea 1 1
Exsanguination 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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