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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 5
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 1
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
2017 415 415
2018 537 537
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 687 931
Entrapment of Device 674 674
Break 629 1239
Adverse Event Without Identified Device or Use Problem 605 1581
Material Separation 374 374
Material Deformation 329 451
Difficult to Remove 249 249
Mechanical Problem 226 226
Physical Resistance/Sticking 215 215
Mechanical Jam 178 178
Suction Problem 171 171
Fracture 138 138
Device Damaged by Another Device 120 120
Difficult to Advance 97 97
Noise, Audible 80 80
Leak/Splash 70 70
Use of Device Problem 67 67
Device Operates Differently Than Expected 53 53
Retraction Problem 52 52
Failure to Advance 44 44
Aspiration Issue 43 43
Positioning Problem 42 42
Material Integrity Problem 32 32
Device-Device Incompatibility 32 32
Defective Device 31 31
Detachment Of Device Component 30 30
Device Markings/Labelling Problem 28 28
Material Twisted/Bent 26 26
Unexpected Shutdown 26 26
Material Split, Cut or Torn 25 25
Fluid/Blood Leak 25 25
Infusion or Flow Problem 24 24
Peeled/Delaminated 21 21
Material Puncture/Hole 21 21
Overheating of Device 20 20
Deformation Due to Compressive Stress 18 18
Intermittent Loss of Power 17 17
Melted 15 15
Off-Label Use 14 14
Device Difficult to Setup or Prepare 14 14
Display or Visual Feedback Problem 13 13
Device Displays Incorrect Message 13 13
Device Remains Activated 13 13
Material Rupture 13 13
Improper or Incorrect Procedure or Method 12 12
Stretched 12 12
Unintended System Motion 12 12
No Apparent Adverse Event 12 12
Device Contamination with Chemical or Other Material 12 12
Device Dislodged or Dislocated 11 11
Insufficient Information 11 11
Difficult or Delayed Activation 11 11
Device Operational Issue 10 10
Hole In Material 10 10
Unintended Movement 10 10
Activation Problem 10 10
Compatibility Problem 10 10
Difficult to Open or Close 9 9
Contamination 9 9
Crack 9 253
Failure to Prime 9 9
Material Fragmentation 8 8
Output Problem 8 8
Missing Information 8 8
Therapeutic or Diagnostic Output Failure 8 8
Device Handling Problem 7 7
Air/Gas in Device 7 7
No Flow 7 7
Material Frayed 7 7
Material Perforation 7 7
Defective Component 7 7
Difficult to Insert 6 6
Inaccurate Information 6 6
Appropriate Term/Code Not Available 6 6
Torn Material 5 5
Migration 5 5
Material Protrusion/Extrusion 5 5
Activation, Positioning or Separation Problem 5 5
Loss of or Failure to Bond 5 5
Failure to Power Up 5 5
Connection Problem 5 5
Obstruction of Flow 5 5
Failure to Calibrate 4 126
Device Misassembled During Manufacturing /Shipping 4 4
Device Packaging Compromised 4 4
Contamination /Decontamination Problem 4 4
Insufficient Flow or Under Infusion 4 4
Device Contamination with Body Fluid 4 4
Kinked 4 4
Migration or Expulsion of Device 4 4
Failure to Shut Off 4 4
Packaging Problem 4 4
Sharp Edges 4 4
Activation Failure 4 4
Wrong Label 3 3
Temperature Problem 3 3
Power Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Delivered as Unsterile Product 3 3
Loose or Intermittent Connection 3 3

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 1116 1116
Foreign Body In Patient 305 305
No Known Impact Or Consequence To Patient 204 326
Vascular Dissection 200 566
Perforation of Vessels 160 282
Device Embedded In Tissue or Plaque 151 151
Embolism/Embolus 128 372
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 115 115
Embolism 110 232
Perforation 78 78
Insufficient Information 72 72
Patient Problem/Medical Problem 65 65
No Code Available 51 51
Unintended Radiation Exposure 50 904
Pain 49 49
Radiation Exposure, Unintended 47 169
Thrombosis/Thrombus 44 44
Vessel Or Plaque, Device Embedded In 42 42
Injury 39 39
Stenosis 38 38
Reocclusion 37 37
Obstruction/Occlusion 29 29
Occlusion 29 29
Vascular System (Circulation), Impaired 29 29
Pseudoaneurysm 28 28
Hematoma 27 27
Iatrogenic Source 26 26
Thrombus 22 22
Intimal Dissection 19 19
Unspecified Tissue Injury 19 19
No Patient Involvement 17 17
Aneurysm 17 17
Death 17 17
Restenosis 16 16
Hemorrhage/Bleeding 14 14
Myocardial Infarction 14 14
Thromboembolism 13 13
Thrombosis 11 11
Ischemia 10 10
Fistula 10 10
Embolus 10 10
Extravasation 10 10
Low Blood Pressure/ Hypotension 9 9
Rupture 9 9
Vasoconstriction 9 9
Sepsis 8 8
Renal Failure 6 6
Cardiac Arrest 6 6
Stroke/CVA 5 5
Peripheral Vascular Disease 5 5
Swelling/ Edema 5 5
Intraoperative Pain 5 5
Blood Loss 4 4
Foreign Body Embolism 4 4
Tissue Damage 4 4
Fever 4 4
Nausea 3 3
Calcium Deposits/Calcification 3 3
Hypersensitivity/Allergic reaction 3 3
No Information 3 3
Laceration(s) 2 2
Muscle Spasm(s) 2 2
Chest Pain 2 2
Dyspnea 2 2
Ecchymosis 2 2
Pulmonary Embolism 2 2
Arrhythmia 2 2
Burning Sensation 2 2
Tachycardia 2 2
Deformity/ Disfigurement 2 2
Atrial Perforation 2 2
Discomfort 2 2
Complaint, Ill-Defined 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Claudication 1 1
Disability 1 1
Loss of consciousness 1 1
Cardiac Tamponade 1 1
Anxiety 1 1
Pneumonia 1 1
Great Vessel Perforation 1 1
Heart Failure 1 1
Vomiting 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Cardiopulmonary Arrest 1 1
Exsanguination 1 1
Failure of Implant 1 1
Unspecified Infection 1 1
High Blood Pressure/ Hypertension 1 1
Hyperplasia 1 1
Foreign Body Reaction 1 1
Bone Fracture(s) 1 1
Gangrene 1 1
Missing Value Reason 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 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Sep-11-2018
8 Spectranetics Corporation II Dec-08-2023
9 Spectranetics Corporation II Jul-14-2017
10 ev3 Inc. I Mar-07-2022
11 ev3 Inc. I Jan-19-2022
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