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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 2
BARD PERIPHERAL VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 3
EXIMO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 4
EXIMO MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
REX MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO ATHEROMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 631 753
2021 734 2930
2022 566 566
2023 575 575
2024 680 680
2025 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Break 689 1299
Detachment of Device or Device Component 603 847
Adverse Event Without Identified Device or Use Problem 520 1496
Entrapment of Device 450 450
Material Separation 270 270
Material Deformation 257 379
Physical Resistance/Sticking 227 227
Difficult to Remove 218 218
Mechanical Jam 193 193
Mechanical Problem 140 140
Fracture 110 110
Suction Problem 107 107
Difficult to Advance 78 78
Noise, Audible 74 74
Device Damaged by Another Device 70 70
Leak/Splash 61 61
Retraction Problem 60 60
Failure to Advance 48 48
Positioning Problem 34 34
Unexpected Shutdown 33 33
Use of Device Problem 31 31
Improper or Incorrect Procedure or Method 27 27
Device Markings/Labelling Problem 27 27
Defective Device 25 25
Deformation Due to Compressive Stress 22 22
Overheating of Device 22 22
Stretched 20 20
Fluid/Blood Leak 19 19
Material Integrity Problem 17 17
Device-Device Incompatibility 16 16
Material Split, Cut or Torn 15 15
Off-Label Use 15 15
Material Puncture/Hole 14 14
Intermittent Loss of Power 14 14
Difficult or Delayed Activation 13 13
Peeled/Delaminated 13 13
Device Difficult to Setup or Prepare 13 13
Melted 13 13
Device Contamination with Chemical or Other Material 12 12
Activation Problem 12 12
No Apparent Adverse Event 11 11
Insufficient Information 11 11
Flushing Problem 10 10
Device Handling Problem 9 9
Device Displays Incorrect Message 9 9
Display or Visual Feedback Problem 9 9
Missing Information 8 8
Difficult to Insert 8 8
Infusion or Flow Problem 8 8
Therapeutic or Diagnostic Output Failure 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1821 2431
No Consequences Or Impact To Patient 271 271
Foreign Body In Patient 216 216
Vascular Dissection 188 554
Embolism/Embolus 182 426
Perforation of Vessels 143 265
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 130 130
Device Embedded In Tissue or Plaque 88 88
Insufficient Information 79 79
Perforation 70 70
No Known Impact Or Consequence To Patient 70 192
Unintended Radiation Exposure 58 912
Thrombosis/Thrombus 54 54
Stenosis 36 36
Obstruction/Occlusion 36 36
Pain 34 34
Hematoma 29 29
Embolism 28 150
Pseudoaneurysm 28 28
Hemorrhage/Bleeding 24 24
Restenosis 20 20
Unspecified Tissue Injury 20 20
Aneurysm 19 19
Vessel Or Plaque, Device Embedded In 19 19
Radiation Exposure, Unintended 18 140
Vascular System (Circulation), Impaired 17 17
Vasoconstriction 16 16
Iatrogenic Source 14 14
Injury 14 14
Ischemia 13 13
Myocardial Infarction 12 12
Fistula 12 12
No Code Available 11 11
Rupture 10 10
Extravasation 8 8
Occlusion 7 7
Cardiac Arrest 6 6
Intimal Dissection 6 6
Renal Failure 6 6
Reocclusion 6 6
Low Blood Pressure/ Hypotension 6 6
Thromboembolism 6 6
Sepsis 5 5
Stroke/CVA 5 5
Swelling/ Edema 5 5
Intraoperative Pain 4 4
Hypersensitivity/Allergic reaction 4 4
Foreign Body Embolism 4 4
Nausea 3 3
Blood Loss 3 3

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Dec-27-2024
2 Cardiovascular Systems Inc II Aug-28-2021
3 Spectranetics Corporation II Dec-16-2024
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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