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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 3
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 4
EXIMO MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 4
EXIMO MEDICAL, LTD.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC
  SUBSTANTIALLY EQUIVALENT 1
REX MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS INC.
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO ATHEROMED, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 618 618
2020 631 753
2021 734 2930
2022 566 566
2023 575 575
2024 485 485

Device Problems MDRs with this Device Problem Events in those MDRs
Detachment of Device or Device Component 645 889
Break 637 1247
Adverse Event Without Identified Device or Use Problem 551 1527
Entrapment of Device 537 537
Material Separation 295 295
Material Deformation 265 387
Difficult to Remove 228 228
Physical Resistance/Sticking 228 228
Mechanical Problem 204 204
Mechanical Jam 194 194
Suction Problem 158 158
Fracture 114 114
Difficult to Advance 92 92
Device Damaged by Another Device 86 86
Noise, Audible 80 80
Leak/Splash 66 66
Use of Device Problem 63 63
Retraction Problem 51 51
Failure to Advance 47 47
Positioning Problem 40 40
Unexpected Shutdown 34 34
Device Markings/Labelling Problem 28 28
Defective Device 26 26
Device-Device Incompatibility 25 25
Material Split, Cut or Torn 25 25
Material Integrity Problem 24 24
Fluid/Blood Leak 24 24
Deformation Due to Compressive Stress 21 21
Infusion or Flow Problem 20 20
Overheating of Device 20 20
Off-Label Use 17 17
Stretched 16 16
Peeled/Delaminated 16 16
Intermittent Loss of Power 16 16
Device Difficult to Setup or Prepare 14 14
Improper or Incorrect Procedure or Method 14 14
Melted 14 14
Material Puncture/Hole 14 14
Material Twisted/Bent 13 13
No Apparent Adverse Event 12 12
Activation Problem 11 11
Display or Visual Feedback Problem 11 11
Unintended System Motion 11 11
Difficult or Delayed Activation 11 11
Device Contamination with Chemical or Other Material 10 10
Failure to Prime 9 9
Device Displays Incorrect Message 9 9
Insufficient Information 9 9
Output Problem 8 8
Missing Information 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1639 2249
No Consequences Or Impact To Patient 623 623
Foreign Body In Patient 240 240
Vascular Dissection 201 567
Embolism/Embolus 169 413
Perforation of Vessels 149 271
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 123 123
No Known Impact Or Consequence To Patient 123 245
Device Embedded In Tissue or Plaque 114 114
Insufficient Information 76 76
Perforation 76 76
Embolism 58 180
Unintended Radiation Exposure 54 908
Thrombosis/Thrombus 50 50
Pain 36 36
Radiation Exposure, Unintended 32 154
Obstruction/Occlusion 32 32
Patient Problem/Medical Problem 32 32
Stenosis 31 31
Vessel Or Plaque, Device Embedded In 31 31
Hematoma 29 29
Injury 28 28
Pseudoaneurysm 27 27
No Code Available 25 25
Vascular System (Circulation), Impaired 25 25
Iatrogenic Source 23 23
Aneurysm 20 20
Unspecified Tissue Injury 20 20
Hemorrhage/Bleeding 19 19
Restenosis 18 18
Vasoconstriction 15 15
Myocardial Infarction 15 15
Occlusion 14 14
Ischemia 11 11
Fistula 11 11
Low Blood Pressure/ Hypotension 10 10
Thromboembolism 10 10
Extravasation 10 10
Rupture 9 9
Reocclusion 9 9
Thrombus 8 8
Intimal Dissection 7 7
Death 7 7
Thrombosis 7 7
Sepsis 6 6
Cardiac Arrest 6 6
Renal Failure 6 6
Swelling/ Edema 5 5
Embolus 4 4
Foreign Body Embolism 4 4

Recalls
Manufacturer Recall Class Date Posted
1 Cardiovascular Systems Inc II Aug-28-2021
2 Spectranetics Corporation II Dec-08-2023
3 ev3 Inc. I Mar-07-2022
4 ev3 Inc. I Jan-19-2022
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