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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
Regulation Description Intraluminal artery stripper.
Product CodeMCW
Regulation Number 870.4875
Device Class 2


Premarket Reviews
ManufacturerDecision
AVINGER, INC.
  SUBSTANTIALLY EQUIVALENT 4
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 5
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
EXIMO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
REX MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
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

Device Problems MDRs with this Device Problem Events in those MDRs
Entrapment of Device 500 500
Detachment of Device or Device Component 478 722
Adverse Event Without Identified Device or Use Problem 383 1359
Material Separation 271 271
Break 237 847
Material Deformation 205 327
Mechanical Problem 195 195
Difficult to Remove 184 184
Suction Problem 133 133
Physical Resistance/Sticking 130 130
Fracture 121 121
Device Damaged by Another Device 114 114
Difficult to Advance 74 74
Mechanical Jam 72 72
Use of Device Problem 65 65
Noise, Audible 59 59
Device Operates Differently Than Expected 53 53
Aspiration Issue 43 43
Leak/Splash 37 37
Positioning Problem 36 36
Detachment Of Device Component 30 30
Device-Device Incompatibility 26 26
Material Integrity Problem 25 25
Material Twisted/Bent 24 24
Failure to Advance 24 24
Infusion or Flow Problem 22 22
Defective Device 21 21
Unexpected Shutdown 20 20
Fluid Leak 19 19
Material Split, Cut or Torn 18 18
Retraction Problem 17 17
Material Puncture/Hole 15 15
Device Remains Activated 13 13
Material Rupture 13 13
Peeled/Delaminated 13 13
Device Difficult to Setup or Prepare 13 13
Intermittent Loss of Power 12 12
Device Dislodged or Dislocated 11 11
Melted 11 11
Deformation Due to Compressive Stress 11 11
Device Operational Issue 10 10
Unintended System Motion 10 10
Hole In Material 10 10
Display or Visual Feedback Problem 10 10
Device Contamination with Chemical or Other Material 10 10
No Apparent Adverse Event 10 10
Insufficient Information 10 10
Compatibility Problem 9 9
Crack 9 253
Difficult to Open or Close 9 9
Device Displays Incorrect Message 9 9
Improper or Incorrect Procedure or Method 9 9
Material Fragmentation 8 8
Off-Label Use 8 8
Failure to Prime 7 7
Material Perforation 7 7
Therapeutic or Diagnostic Output Failure 7 7
No Flow 7 7
Output Problem 6 6
Unintended Movement 6 6
Defective Component 6 6
Stretched 6 6
Difficult or Delayed Activation 6 6
Material Frayed 6 6
Contamination 5 5
Failure to Power Up 5 5
Overheating of Device 5 5
Difficult to Insert 5 5
Loss of or Failure to Bond 5 5
Obstruction of Flow 5 5
Torn Material 5 5
Appropriate Term/Code Not Available 5 5
Failure to Shut Off 4 4
Material Protrusion/Extrusion 4 4
Migration 4 4
Activation Problem 4 4
Device Packaging Compromised 4 4
Activation, Positioning or SeparationProblem 4 4
Device Misassembled During Manufacturing /Shipping 4 4
Contamination /Decontamination Problem 4 4
Insufficient Flow or Under Infusion 4 4
Kinked 4 4
Migration or Expulsion of Device 4 4
Loose or Intermittent Connection 3 3
Pumping Stopped 3 3
Difficult to Flush 3 3
Device Markings/Labelling Problem 3 3
Connection Problem 3 3
Failure to Calibrate 3 125
Device Stops Intermittently 3 3
Split 3 3
Patient-Device Incompatibility 3 3
Temperature Problem 3 3
Activation Failure 3 3
Device Contaminated During Manufacture or Shipping 3 3
Power Problem 3 3
Device Handling Problem 2 2
Packaging Problem 2 2
Physical Property Issue 2 2
Manufacturing, Packaging or Shipping Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 1116 1116
No Clinical Signs, Symptoms or Conditions 574 1184
Foreign Body In Patient 210 210
No Known Impact Or Consequence To Patient 204 326
Vascular Dissection 135 501
Device Embedded In Tissue or Plaque 126 126
Perforation of Vessels 114 236
Embolism 110 232
Patient Problem/Medical Problem 65 65
Perforation 55 55
No Code Available 51 51
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 50 50
Radiation Exposure, Unintended 47 169
Vessel Or Plaque, Device Embedded In 42 42
Insufficient Information 41 41
Injury 39 39
Reocclusion 37 37
Pain 32 32
Vascular System (Circulation), Impaired 29 29
Occlusion 29 29
Embolism/Embolus 29 273
Iatrogenic Source 26 26
Stenosis 22 22
Thrombus 22 22
Pseudoaneurysm 20 20
Hematoma 19 19
Intimal Dissection 19 19
Unintended Radiation Exposure 19 873
Unspecified Tissue Injury 18 18
No Patient Involvement 17 17
Death 17 17
Thrombosis/Thrombus 14 14
Obstruction/Occlusion 13 13
Thrombosis 11 11
Thromboembolism 10 10
Embolus 10 10
Myocardial Infarction 10 10
Aneurysm 9 9
Hemorrhage/Bleeding 8 8
Low Blood Pressure/ Hypotension 7 7
Extravasation 7 7
Rupture 7 7
Fistula 6 6
Sepsis 5 5
Peripheral Vascular Disease 5 5
Renal Failure 4 4
Tissue Damage 4 4
Vasoconstriction 4 4
Blood Loss 4 4
Fever 4 4
Stroke/CVA 4 4
Calcium Deposits/Calcification 3 3
Cardiac Arrest 3 3
Nausea 3 3
Ischemia 3 3
Hypersensitivity/Allergic reaction 3 3
No Information 3 3
Restenosis 3 3
Swelling/ Edema 2 2
Intraoperative Pain 2 2
Muscle Spasm(s) 2 2
Pulmonary Embolism 2 2
Dyspnea 2 2
Atrial Perforation 2 2
Deformity/ Disfigurement 2 2
Disability 1 1
Loss of consciousness 1 1
Respiratory Acidosis 1 1
Respiratory Failure 1 1
Discomfort 1 1
Complaint, Ill-Defined 1 1
Shaking/Tremors 1 1
Skin Tears 1 1
Claudication 1 1
Diminished Pulse Pressure 1 1
Tachycardia 1 1
Pneumonia 1 1
Cardiac Tamponade 1 1
Heart Failure 1 1
Vomiting 1 1
Burning Sensation 1 1
Great Vessel Perforation 1 1
Chest Pain 1 1
Exsanguination 1 1
Cardiopulmonary Arrest 1 1
Arrhythmia 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Burn(s) 1 1
Laceration(s) 1 1
Foreign Body Reaction 1 1
Bone Fracture(s) 1 1
Gangrene 1 1
Failure of Implant 1 1
Hyperplasia 1 1
Alteration In Body Temperature 1 1
Superficial (First Degree) Burn 1 1
Test Result 1 1
Missing Value Reason 1 1
Not Applicable 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 Jul-14-2017
9 ev3 Inc. I Jan-19-2022
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