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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
ATHEROMED INC
  SUBSTANTIALLY EQUIVALENT 2
AVINGER, INC
  SUBSTANTIALLY EQUIVALENT 1
AVINGER, INC.
  SUBSTANTIALLY EQUIVALENT 9
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
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
CARDIO SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCUALR SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEM, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 7
CARDIOVASCULAR SYSTEMS INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
EV3 INC
  SUBSTANTIALLY EQUIVALENT 3
EXIMO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 5
EXIMO MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
PATHWAY MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 13
REX MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
REX MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
STRAUB MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO ATHEROMED INC
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO ATHEROMED INC.
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO ATHEROMED, INC.
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 210 210
2015 377 377
2016 409 409
2017 415 415
2018 537 537
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
Entrapment of Device 807 807
Adverse Event Without Identified Device or Use Problem 795 1771
Detachment of Device or Device Component 723 967
Break 669 1279
Material Separation 429 429
Material Deformation 387 509
Difficult to Remove 297 297
Mechanical Problem 227 227
Physical Resistance/Sticking 213 213
Mechanical Jam 180 180
Suction Problem 170 170
Fracture 167 167
Device Damaged by Another Device 132 132
Difficult to Advance 109 109
Aspiration Issue 106 106
Device Operates Differently Than Expected 93 93
Noise, Audible 83 83
Use of Device Problem 79 79
Leak/Splash 72 72
Detachment Of Device Component 72 72
Failure to Advance 71 71
Retraction Problem 59 59
Sticking 50 50
Insufficient Information 46 46
Positioning Problem 43 43
Device-Device Incompatibility 40 40
Defective Device 34 34
Device Contamination with Chemical or Other Material 32 32
Material Integrity Problem 32 32
Infusion or Flow Problem 30 30
Material Twisted/Bent 29 29
Device Markings/Labelling Problem 28 28
Hole In Material 28 28
Material Fragmentation 27 27
Fluid/Blood Leak 26 26
Unexpected Shutdown 26 26
Material Split, Cut or Torn 25 25
Material Puncture/Hole 23 23
Peeled/Delaminated 22 22
Overheating of Device 22 22
Device Dislodged or Dislocated 20 20
Deformation Due to Compressive Stress 17 17
Intermittent Loss of Power 17 17
Melted 17 17
Material Rupture 17 17
Improper or Incorrect Procedure or Method 16 16
Device Difficult to Setup or Prepare 15 15
Off-Label Use 14 14
Device Displays Incorrect Message 14 14
Device Remains Activated 13 13
Display or Visual Feedback Problem 13 13
Crack 13 257
Unintended System Motion 12 12
Stretched 12 12
No Apparent Adverse Event 12 12
Torn Material 11 11
Unintended Movement 11 11
Compatibility Problem 11 11
Difficult to Open or Close 11 11
Difficult or Delayed Activation 11 11
Physical Resistance 10 10
Material Perforation 10 10
Failure to Prime 10 10
Kinked 10 10
Contamination 10 10
Device Operational Issue 10 10
Activation Problem 10 10
Material Frayed 9 9
Obstruction of Flow 9 9
Defective Component 8 8
Device Stops Intermittently 8 8
Difficult to Insert 8 8
Migration or Expulsion of Device 8 8
Missing Information 8 8
No Flow 8 8
Therapeutic or Diagnostic Output Failure 8 8
Output Problem 8 8
Device Handling Problem 7 7
Complete Blockage 7 7
Device Inoperable 7 7
Loss of Power 6 6
Occlusion Within Device 6 6
Air/Gas in Device 6 6
Inaccurate Information 6 6
Appropriate Term/Code Not Available 6 6
Failure to Shut Off 6 6
Activation, Positioning or Separation Problem 6 6
Device Packaging Compromised 6 6
Connection Problem 5 5
Material Protrusion/Extrusion 5 5
Temperature Problem 5 5
Migration 5 5
Loss of or Failure to Bond 5 5
Failure to Power Up 5 5
Device Contamination with Body Fluid 4 4
Insufficient Flow or Under Infusion 4 4
Failure to Calibrate 4 126
Activation Failure 4 4
Sharp Edges 4 4
Packaging Problem 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1474 1474
No Clinical Signs, Symptoms or Conditions 1437 2047
Foreign Body In Patient 355 355
No Known Impact Or Consequence To Patient 344 466
Vascular Dissection 238 604
Device Embedded In Tissue or Plaque 204 204
Perforation of Vessels 191 313
Embolism 145 267
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 114 114
Embolism/Embolus 114 358
Perforation 106 106
Reocclusion 87 87
Insufficient Information 73 73
No Code Available 72 72
Patient Problem/Medical Problem 72 72
Pain 59 59
Vessel Or Plaque, Device Embedded In 50 50
Unintended Radiation Exposure 49 903
Radiation Exposure, Unintended 47 169
Intimal Dissection 46 46
Occlusion 45 45
Injury 42 42
No Patient Involvement 41 41
Thrombosis/Thrombus 41 41
Stenosis 40 40
Thrombus 40 40
Vascular System (Circulation), Impaired 36 36
Death 35 35
Pseudoaneurysm 34 34
No Information 33 33
Hematoma 31 31
Obstruction/Occlusion 28 28
Iatrogenic Source 26 26
Unspecified Tissue Injury 19 19
Embolus 18 18
Aneurysm 18 18
Hemorrhage/Bleeding 17 17
Thrombosis 17 17
Tissue Damage 16 16
Calcium Deposits/Calcification 16 16
Restenosis 16 16
Thromboembolism 16 16
Myocardial Infarction 15 15
Fistula 13 13
Extravasation 12 12
Low Blood Pressure/ Hypotension 11 11
Ischemia 10 10
Vasoconstriction 10 10
Rupture 9 9
Sepsis 8 8
Claudication 8 8
Cardiac Arrest 7 7
Stroke/CVA 7 7
Renal Failure 6 6
Peripheral Vascular Disease 5 5
Intraoperative Pain 5 5
Blood Loss 5 5
Swelling/ Edema 5 5
Foreign Body Embolism 4 4
Nausea 4 4
Muscle Spasm(s) 4 4
Fever 4 4
Laceration(s) 3 3
Hypersensitivity/Allergic reaction 3 3
Dyspnea 3 3
Pulmonary Embolism 3 3
Swelling 3 3
Discomfort 3 3
Complaint, Ill-Defined 3 3
Burning Sensation 2 2
Great Vessel Perforation 2 2
Tachycardia 2 2
Unspecified Infection 2 2
Arrhythmia 2 2
Ecchymosis 2 2
Chest Pain 2 2
Cardiopulmonary Arrest 2 2
High Blood Pressure/ Hypertension 2 2
Exsanguination 2 2
Atrial Perforation 2 2
Deformity/ Disfigurement 2 2
Disability 2 2
Alteration In Body Temperature 2 2
Superficial (First Degree) Burn 1 1
Test Result 1 1
Missing Value Reason 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Not Applicable 1 1
Numbness 1 1
Loss of consciousness 1 1
Prolapse 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Sudden Cardiac Death 1 1
Diminished Pulse Pressure 1 1
Unspecified Vascular Problem 1 1
Respiratory Arrest 1 1
Unspecified Kidney or Urinary Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Jun-24-2009
2 Boston Scientific Corporation II Apr-10-2017
3 Cardiovascular Systems Inc II Aug-28-2021
4 Cardiovascular Systems Inc II Oct-11-2018
5 Cardiovascular Systems Inc II Apr-10-2017
6 Cardiovascular Systems Inc II Apr-10-2017
7 Cardiovascular Systems Inc II Feb-22-2017
8 Cardiovascular Systems Inc II Jun-27-2016
9 Cardiovascular Systems, Inc. I Aug-14-2014
10 Cardiovascular Systems, Inc. II Jul-09-2012
11 Cardiovascular Systems, Inc. II Sep-10-2009
12 Cardiovascular Systems, Inc. II Apr-17-2009
13 Elana, Inc. II Apr-18-2013
14 Ev3, Inc. II Mar-18-2010
15 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Sep-11-2018
16 Spectranetics Corp. II Feb-05-2016
17 Spectranetics Corporation II Dec-08-2023
18 Spectranetics Corporation II Jul-14-2017
19 Spectranetics Corporation II Nov-28-2016
20 ev3 Inc. I Mar-07-2022
21 ev3 Inc. I Jan-19-2022
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