Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
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 145 145

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 674 918
Entrapment of Device 671 671
Break 611 1221
Adverse Event Without Identified Device or Use Problem 580 1556
Material Separation 372 372
Material Deformation 322 444
Difficult to Remove 245 245
Mechanical Problem 225 225
Physical Resistance/Sticking 213 213
Mechanical Jam 174 174
Suction Problem 170 170
Fracture 138 138
Device Damaged by Another Device 120 120
Difficult to Advance 97 97
Noise, Audible 80 80
Leak/Splash 68 68
Use of Device Problem 67 67
Device Operates Differently Than Expected 53 53
Retraction Problem 51 51
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
Overheating of Device 20 20
Material Puncture/Hole 20 20
Intermittent Loss of Power 17 17
Deformation Due to Compressive Stress 16 16
Melted 15 15
Device Difficult to Setup or Prepare 14 14
Off-Label Use 14 14
Display or Visual Feedback Problem 13 13
Device Displays Incorrect Message 13 13
Material Rupture 13 13
Device Remains Activated 13 13
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
Stretched 11 11
Improper or Incorrect Procedure or Method 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
No Flow 7 7
Device Handling Problem 7 7
Material Frayed 7 7
Defective Component 7 7
Material Perforation 7 7
Difficult to Insert 6 6
Appropriate Term/Code Not Available 6 6
Air/Gas in Device 6 6
Inaccurate Information 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
Obstruction of Flow 5 5
Connection Problem 5 5
Device Misassembled During Manufacturing /Shipping 4 4
Contamination /Decontamination Problem 4 4
Failure to Calibrate 4 126
Device Contamination with Body Fluid 4 4
Insufficient Flow or Under Infusion 4 4
Kinked 4 4
Migration or Expulsion of Device 4 4
Device Packaging Compromised 4 4
Failure to Shut Off 4 4
Activation Failure 4 4
Sharp Edges 4 4
Wrong Label 3 3
Temperature Problem 3 3
Packaging Problem 3 3
Power Problem 3 3
Device Contaminated During Manufacture or Shipping 3 3
Difficult to Flush 3 3
Complete Blockage 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 1116 1116
Foreign Body In Patient 304 304
No Known Impact Or Consequence To Patient 204 326
Vascular Dissection 191 557
Perforation of Vessels 159 281
Device Embedded In Tissue or Plaque 151 151
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 114 114
Embolism/Embolus 114 358
Embolism 110 232
Perforation 75 75
Insufficient Information 72 72
Patient Problem/Medical Problem 65 65
No Code Available 51 51
Unintended Radiation Exposure 49 903
Pain 49 49
Radiation Exposure, Unintended 47 169
Vessel Or Plaque, Device Embedded In 42 42
Thrombosis/Thrombus 41 41
Injury 39 39
Reocclusion 37 37
Occlusion 29 29
Vascular System (Circulation), Impaired 29 29
Pseudoaneurysm 28 28
Stenosis 28 28
Obstruction/Occlusion 27 27
Iatrogenic Source 26 26
Hematoma 24 24
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 13 13
Myocardial Infarction 13 13
Thromboembolism 12 12
Thrombosis 11 11
Fistula 10 10
Embolus 10 10
Extravasation 10 10
Low Blood Pressure/ Hypotension 9 9
Ischemia 9 9
Rupture 9 9
Sepsis 8 8
Vasoconstriction 7 7
Renal Failure 6 6
Cardiac Arrest 6 6
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
Stroke/CVA 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
-
-