• 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 Back To Search Results
Device temporary carotid catheter for embolic capture
Regulation Description Percutaneous catheter.
Definition This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can be placed either distally to the lesion or proximally depending on the design of the device and intended use. The filter or balloon is used to capture embolic material in a manner that may protect or prevent a stroke or other cerebral vascular sequelae. The embolic capture device is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures i
Product CodeNTE
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 8
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 4
LUMEN
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
No Known Device Problem 296
Difficult to remove 227
Unknown (for use when the device problem is not known) 207
Other (for use when an appropriate device code cannot be identified) 169
Physical resistance 77
Use of Device Issue 38
Stretched 31
Detachment of device component 27
Source, detachment from 25
Migration of device or device component 22
Kinked 21
Unraveled material 21
Detachment of device or device component 21
Improper or incorrect procedure or method 19
Difficult to position 16
Break 16
Failure to capture 15
Occlusion within device 14
No code available 14
No Information 13
Device damaged prior to use 13
Leak 12
Tears, rips, holes in device, device material 11
Material frayed 10
Bent 9
Failure to advance 9
Retraction problem 8
Fracture 8
Torn material 7
Material deformation 6
Deflation issue 6
Device Difficult to Setup or Prepare 6
Material separation 5
Premature deployment 5
Difficult to insert 5
Foreign material present in device 5
Device or device component damaged by another device 4
Capturing issue 4
Mislabeled 4
Failure to deploy 4
Dissection 4
Entrapment of device or device component 4
Defective component 4
Method, improper/incorrect 3
Device remains implanted 3
Deflation, cause unknown 3
Hole in material 3
Inflation issue 3
Deployment issue 3
Device operates differently than expected 3
Device, removal of (non-implant) 2
Membrane tear(s) 2
Device clogged 2
Collapse 2
Burst 2
Filter 2
Foreign material 2
Size incorrect for patient 2
Twisting 2
Defective item 2
Device Issue 2
Obstruction within device 2
Failure to align 1
Tear, rip or hole in device packaging 1
Pressure, insufficient 1
Locking mechanism failure 1
Split 1
Component missing 1
Out-of-box failure 1
Failure to deliver 1
Inaccurate delivery 1
Material perforation 1
Uncoiled 1
Undersensing 1
Tip breakage 1
Sticking 1
Shaft break 1
Device, or device fragments remain in patient 1
Material rupture 1
Air leak 1
Dislodged 1
Filter break(s) 1
Restricted flowrate 1
Difficult to fold or unfold 1
Biofilm coating in device 1
Blockage within device or device component 1
Normal 1
Peeled 1
Interference 1
Looping 1
Loose or intermittent connection 1
Folded 1
Traditional use 1
Blocked connection 1
Disinfection or Sterilization Issue at User Location 1
Delamination 1
Device markings issue 1
No flow 1
Difficult to advance 1
Difficult to open or close 1
Total Device Problems 1525

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 1 0 0 0 0 1 1 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Jan-31-2013
2 Boston Scientific Corporation II Oct-14-2008
3 Medtronic Vascular, Inc. II Mar-27-2014

-
-