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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 4
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIO FLOW INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIO FLOW, INC.
  SUBSTANTIALLY EQUIVALENT 2
CARDIOVASCUALR SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 6
EXIMO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 5
EXIMO MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 566 566
2023 575 575
2024 613 613

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 750 994
Break 714 1324
Entrapment of Device 659 659
Adverse Event Without Identified Device or Use Problem 625 1601
Material Separation 371 371
Material Deformation 326 448
Difficult to Remove 255 255
Physical Resistance/Sticking 239 239
Mechanical Problem 237 237
Mechanical Jam 221 221
Suction Problem 184 184
Fracture 130 130
Device Damaged by Another Device 109 109
Difficult to Advance 102 102
Noise, Audible 89 89
Leak/Splash 76 76
Use of Device Problem 66 66
Retraction Problem 59 59
Failure to Advance 53 53
Positioning Problem 44 44
Unexpected Shutdown 37 37
Defective Device 32 32
Device-Device Incompatibility 31 31
Material Integrity Problem 29 29
Device Markings/Labelling Problem 28 28
Deformation Due to Compressive Stress 27 27
Material Split, Cut or Torn 27 27
Fluid/Blood Leak 25 25
Infusion or Flow Problem 24 24
Material Twisted/Bent 23 23
Improper or Incorrect Procedure or Method 22 22
Overheating of Device 22 22
Peeled/Delaminated 21 21
Stretched 19 19
Material Puncture/Hole 19 19
Device Operates Differently Than Expected 18 18
Aspiration Issue 18 18
Off-Label Use 18 18
Intermittent Loss of Power 18 18
Device Contamination with Chemical or Other Material 16 16
Device Difficult to Setup or Prepare 14 14
Melted 14 14
Display or Visual Feedback Problem 14 14
Device Remains Activated 13 13
Unintended System Motion 13 13
Activation Problem 12 12
Difficult or Delayed Activation 12 12
No Apparent Adverse Event 12 12
Insufficient Information 12 12
Detachment Of Device Component 10 10

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1733 2343
No Consequences Or Impact To Patient 911 911
Foreign Body In Patient 286 286
Vascular Dissection 234 600
No Known Impact Or Consequence To Patient 177 299
Embolism/Embolus 174 418
Perforation of Vessels 169 291
Device Embedded In Tissue or Plaque 142 142
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 128 128
Embolism 82 204
Perforation 80 80
Insufficient Information 78 78
Unintended Radiation Exposure 55 909
Patient Problem/Medical Problem 53 53
Thrombosis/Thrombus 51 51
Pain 42 42
No Code Available 41 41
Radiation Exposure, Unintended 40 162
Vessel Or Plaque, Device Embedded In 39 39
Stenosis 38 38
Injury 37 37
Hematoma 34 34
Obstruction/Occlusion 34 34
Pseudoaneurysm 31 31
Vascular System (Circulation), Impaired 26 26
Iatrogenic Source 26 26
Hemorrhage/Bleeding 22 22
Aneurysm 21 21
Restenosis 20 20
Unspecified Tissue Injury 20 20
Occlusion 20 20
Vasoconstriction 16 16
Thrombus 16 16
Myocardial Infarction 15 15
Reocclusion 15 15
Death 12 12
Intimal Dissection 12 12
Fistula 12 12
Ischemia 12 12
Low Blood Pressure/ Hypotension 10 10
Extravasation 10 10
Thromboembolism 10 10
No Patient Involvement 10 10
Rupture 9 9
Thrombosis 9 9
Cardiac Arrest 7 7
Sepsis 7 7
Embolus 7 7
Renal Failure 6 6
Swelling/ Edema 5 5

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 Spectranetics Corporation II Dec-08-2023
5 ev3 Inc. I Mar-07-2022
6 ev3 Inc. I Jan-19-2022
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