• 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 catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Definition For the treatment of atrial flutter.
Product CodeOAD
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
14 8 9 12 21 19 30 25 24 6

Device Problems
Detachment of device component 189
No Known Device Problem 145
Leak 98
Device operates differently than expected 44
Kinked 18
Temperature issue 16
Bent 13
Charred 10
Break 8
Difficult to remove 8
No Information 8
Component(s), broken 6
Fluid leak 6
Crack 5
Material discolored 4
High impedance 4
Material separation 4
Inadequate storage 4
Device packaging compromised 4
Device sensing issue 3
Device displays error message 3
Material frayed 3
Burn of device or device component 3
Inability to irrigate 2
Electrical issue 2
Device remains activated 2
Loose or intermittent connection 2
Mechanical issue 2
Difficult or delayed activation 2
Noise, Audible 2
Device damaged prior to use 2
Tear, rip or hole in device packaging 2
Cut in material 2
Incorrect or inadequate test results 1
Split 1
Low impedance 1
Defective component 1
Device contamination with blood or blood product 1
Device Issue 1
Difficult to advance 1
Electronic property issue 1
Failure to shut off 1
Foreign material present in device 1
Impedance issue 1
Improper flow or infusion 1
Material deformation 1
No code available 1
Communication or transmission issue 1
Torn material 1
Occlusion within device 1
Overheating of device or device component 1
Unsealed device packaging 1
Difficult to position 1
Loss of power 1
Prep, failure to 1
Material puncture 1
R on T phenomenon 1
Device inoperable 1
Use of Device Issue 1
Failure to read input signal 1
Smoking 1
Restricted flowrate 1
Fracture 1
Hole in material 1
Device alarm system issue 1
Artifact 1
Degraded 1
Total Device Problems 660

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 1 0
Class II 0 0 0 1 0 1 2 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corp II Dec-22-2015
2 Boston Scientific Corp I Mar-02-2015
3 Boston Scientific Corporation II Jun-16-2014
4 Endologix Inc II Jan-11-2010
5 St Jude Medical Inc II Feb-14-2012
6 St. Jude Medical II Nov-08-2013
7 St. Jude Medical II Nov-06-2013

-
-