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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 1
AVINGER, INC.
  SUBSTANTIALLY EQUIVALENT 8
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 6
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXIMO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 5
EXIMO MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
REX MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS, INC.
  SUBSTANTIALLY EQUIVALENT 4
STRAUB MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO ATHEROMED INC
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO ATHEROMED INC.
  SUBSTANTIALLY EQUIVALENT 2
VOLCANO ATHEROMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
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 745 745
Detachment of Device or Device Component 693 937
Adverse Event Without Identified Device or Use Problem 680 1656
Break 621 1231
Material Separation 405 405
Material Deformation 360 482
Difficult to Remove 256 256
Mechanical Problem 225 225
Physical Resistance/Sticking 213 213
Mechanical Jam 176 176
Suction Problem 170 170
Fracture 146 146
Device Damaged by Another Device 123 123
Difficult to Advance 99 99
Aspiration Issue 89 89
Noise, Audible 80 80
Device Operates Differently Than Expected 71 71
Leak/Splash 71 71
Use of Device Problem 70 70
Retraction Problem 52 52
Failure to Advance 47 47
Positioning Problem 42 42
Detachment Of Device Component 40 40
Defective Device 34 34
Device-Device Incompatibility 34 34
Material Integrity Problem 32 32
Device Markings/Labelling Problem 28 28
Material Twisted/Bent 26 26
Unexpected Shutdown 26 26
Fluid/Blood Leak 26 26
Material Split, Cut or Torn 25 25
Infusion or Flow Problem 24 24
Hole In Material 23 23
Overheating of Device 22 22
Peeled/Delaminated 22 22
Material Puncture/Hole 21 21
Intermittent Loss of Power 17 17
Material Rupture 16 16
Deformation Due to Compressive Stress 16 16
Melted 16 16
Off-Label Use 14 14
Device Difficult to Setup or Prepare 14 14
Improper or Incorrect Procedure or Method 14 14
Device Contamination with Chemical or Other Material 14 14
Device Dislodged or Dislocated 14 14
Insufficient Information 13 13
Device Remains Activated 13 13
Device Displays Incorrect Message 13 13
Display or Visual Feedback Problem 13 13
Unintended System Motion 12 12
No Apparent Adverse Event 12 12
Compatibility Problem 11 11
Crack 11 255
Difficult or Delayed Activation 11 11
Stretched 11 11
Material Fragmentation 10 10
Contamination 10 10
Difficult to Open or Close 10 10
Device Operational Issue 10 10
Unintended Movement 10 10
Activation Problem 10 10
Material Perforation 9 9
Failure to Prime 9 9
Material Frayed 8 8
Missing Information 8 8
Therapeutic or Diagnostic Output Failure 8 8
Output Problem 8 8
No Flow 7 7
Device Handling Problem 7 7
Complete Blockage 7 7
Migration or Expulsion of Device 7 7
Difficult to Insert 7 7
Defective Component 7 7
Obstruction of Flow 7 7
Appropriate Term/Code Not Available 6 6
Torn Material 6 6
Air/Gas in Device 6 6
Inaccurate Information 6 6
Migration 5 5
Connection Problem 5 5
Activation, Positioning or Separation Problem 5 5
Device Packaging Compromised 5 5
Material Protrusion/Extrusion 5 5
Device Stops Intermittently 5 5
Loss of or Failure to Bond 5 5
Kinked 5 5
Failure to Power Up 5 5
Contamination /Decontamination Problem 4 4
Failure to Calibrate 4 126
Device Contamination with Body Fluid 4 4
Insufficient Flow or Under Infusion 4 4
Device Inoperable 4 4
Failure to Shut Off 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Activation Failure 4 4
Sharp Edges 4 4
Packaging Problem 4 4
Power Problem 3 3
Temperature Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3

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 1277 1277
Foreign Body In Patient 331 331
No Known Impact Or Consequence To Patient 253 375
Vascular Dissection 215 581
Perforation of Vessels 182 304
Device Embedded In Tissue or Plaque 161 161
Embolism 126 248
Embolism/Embolus 114 358
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 114 114
Perforation 82 82
Insufficient Information 72 72
Patient Problem/Medical Problem 71 71
Reocclusion 63 63
No Code Available 59 59
Pain 50 50
Unintended Radiation Exposure 49 903
Radiation Exposure, Unintended 47 169
Vessel Or Plaque, Device Embedded In 46 46
Thrombosis/Thrombus 41 41
Injury 40 40
Occlusion 35 35
Intimal Dissection 31 31
No Patient Involvement 30 30
Vascular System (Circulation), Impaired 29 29
Pseudoaneurysm 29 29
Death 29 29
Stenosis 29 29
Thrombus 29 29
Obstruction/Occlusion 28 28
Hematoma 28 28
Iatrogenic Source 26 26
Unspecified Tissue Injury 19 19
Aneurysm 17 17
Restenosis 16 16
Embolus 15 15
Hemorrhage/Bleeding 14 14
Myocardial Infarction 14 14
Thromboembolism 14 14
Thrombosis 11 11
Low Blood Pressure/ Hypotension 11 11
Fistula 11 11
Tissue Damage 11 11
Extravasation 10 10
Ischemia 9 9
Rupture 9 9
Sepsis 8 8
Vasoconstriction 7 7
Cardiac Arrest 7 7
Renal Failure 6 6
Peripheral Vascular Disease 5 5
Blood Loss 5 5
Intraoperative Pain 5 5
Swelling/ Edema 5 5
No Information 5 5
Foreign Body Embolism 4 4
Fever 4 4
Stroke/CVA 4 4
Nausea 4 4
Calcium Deposits/Calcification 4 4
Hypersensitivity/Allergic reaction 3 3
Laceration(s) 2 2
Muscle Spasm(s) 2 2
Chest Pain 2 2
Dyspnea 2 2
Ecchymosis 2 2
Cardiopulmonary Arrest 2 2
Pulmonary Embolism 2 2
Arrhythmia 2 2
Tachycardia 2 2
Burning Sensation 2 2
Deformity/ Disfigurement 2 2
Atrial Perforation 2 2
Discomfort 2 2
Claudication 2 2
Alteration In Body Temperature 1 1
Superficial (First Degree) Burn 1 1
Diminished Pulse Pressure 1 1
Test Result 1 1
Unspecified Vascular Problem 1 1
Respiratory Arrest 1 1
Unspecified Kidney or Urinary Problem 1 1
Localized Skin Lesion 1 1
Missing Value Reason 1 1
Arteriosclerosis/ Atherosclerosis 1 1
Not Applicable 1 1
Complaint, Ill-Defined 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Sudden Cardiac Death 1 1
Disability 1 1
Loss of consciousness 1 1
Cardiac Tamponade 1 1
Cardiogenic Shock 1 1
Anxiety 1 1
Great Vessel Perforation 1 1
Nipple Sensation Changes 1 1
Heart Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Apr-10-2017
2 Cardiovascular Systems Inc II Aug-28-2021
3 Cardiovascular Systems Inc II Oct-11-2018
4 Cardiovascular Systems Inc II Apr-10-2017
5 Cardiovascular Systems Inc II Apr-10-2017
6 Cardiovascular Systems Inc II Feb-22-2017
7 Cardiovascular Systems Inc II Jun-27-2016
8 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Sep-11-2018
9 Spectranetics Corp. II Feb-05-2016
10 Spectranetics Corporation II Dec-08-2023
11 Spectranetics Corporation II Jul-14-2017
12 Spectranetics Corporation II Nov-28-2016
13 ev3 Inc. I Mar-07-2022
14 ev3 Inc. I Jan-19-2022
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