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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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New Search Show TPLC since Back To Search Results
Device catheter, peripheral, atherectomy
Regulation Description Intraluminal artery stripper.
Product CodeMCW
Regulation Number 870.4875
Device Class 2


Premarket Reviews
ManufacturerDecision
ATHEROMED INC
  SUBSTANTIALLY EQUIVALENT 2
AVINGER, INC.
  SUBSTANTIALLY EQUIVALENT 7
BAYER MEDICAL CARE INC.
  SUBSTANTIALLY EQUIVALENT 1
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS INTERNATIONAL BV
  SUBSTANTIALLY EQUIVALENT 2
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS, INC.
  SUBSTANTIALLY EQUIVALENT 5
STRAUB MEDICAL AG
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Catheter 368
Adverse Event Without Identified Device or Use Problem 350
Entrapment of Device 327
Material Separation 169
Detachment of Device or device Component 167
Material Deformation 112
Aspiration Issue 99
Break 68
Mechanical Problem 67
Device Operates Differently Than Expected 67
Difficult to Remove 55
Suction Problem 49
Device Damaged by Another Device 49
Fracture 35
Detachment Of Device Component 30
Mechanical Jam 26
Use of Device Problem 24
Guidewire 22
Material Fragmentation 20
Device-Device Incompatibility 17
Tip 17
Leak / Splash 15
Noise, Audible 15
Difficult to Advance 15
Shaft 14
Material Integrity Problem 14
Material Twisted / Bent 12
Material Puncture / Hole 11
Material Rupture 11
Device Contamination with Chemical or Other Material 11
Torn Material 10
Device Operational Issue 10
Infusion or Flow Problem 9
Failure to Advance 9
Retraction Problem 9
Difficult to Open or Close 9
Device Stops Intermittently 7
Improper or Incorrect Procedure or Method 7
Defective Device 7
Hole In Material 7
Material Split, Cut or Torn 6
Device Remains Activated 5
Unintended Movement 5
Peeled / Delaminated 5
Material Perforation 5
Insufficient Information 4
Fluid Leak 4
Kinked 4
Positioning Problem 4
Physical Resistance / Sticking 4
Intermittent loss of power 4
Unexpected Shutdown 4
Unintended System Motion 4
Deformation Due to Compressive Stress 4
Obstruction of Flow 4
Compatibility Problem 4
Defective Component 3
Device Inoperable 3
Contamination During Use 3
Physical Resistance 3
Wire 3
Contamination / decontamination Problem 3
Device Packaging Compromised 3
Complete Blockage 3
Device Misassembled During Manufacturing / Shipping 3
Display or Visual Feedback Problem 3
Crack 2
Failure to Shut Off 2
Cut In Material 2
Split 2
Material Distortion 2
Incorrect Device Or Component Shipped 2
Poor Quality Image 2
Partial Blockage 2
Positioning Failure 2
Device Issue 2
Failure to Power Up 2
Off-Label Use 2
Material Protrusion / Extrusion 2
Device Displays Incorrect Message 2
Electrical /Electronic Property Problem 2
Material Frayed 2
Loss of or Failure to Bond 2
Device Dislodged or Dislocated 2
Appropriate Term/Code Not Available 2
Solder Joint Fracture 2
Tear, Rip or Hole in Device Packaging 1
Unstable 1
Battery Problem 1
Failure to Prime 1
Material Disintegration 1
Escape 1
No Apparent Adverse Event 1
Delamination 1
Activation, Positioning or Separation Problem 1
Difficult to Flush 1
Melted 1
Failure to Cut 1
Metal Shedding Debris 1
Radiation Leak 1
Total Device Problems 2494

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Apr-10-2017
2 Cardiovascular Systems Inc II Oct-11-2018
3 Cardiovascular Systems Inc II Apr-10-2017
4 Cardiovascular Systems Inc II Apr-10-2017
5 Cardiovascular Systems Inc II Feb-22-2017
6 Cardiovascular Systems Inc II Jun-27-2016
7 Cardiovascular Systems, Inc. I Aug-14-2014
8 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Sep-11-2018
9 Spectranetics Corp. II Feb-05-2016
10 Spectranetics Corporation II Jul-14-2017
11 Spectranetics Corporation II Nov-28-2016

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