• 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 43

Device Problems
Detachment of device component 189
No Known Device Problem 153
Leak 98
Device operates differently than expected 44
Kinked 20
Temperature issue 16
Bent 15
Break 12
Charred 10
Difficult to remove 8
No Information 8
Component(s), broken 6
Fluid leak 6
Crack 5
Material separation 5
Inadequate storage 4
Material discolored 4
High impedance 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
Fracture 2
Device remains activated 2
Loose or intermittent connection 2
Mechanical issue 2
Unsealed device packaging 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
Device or device component damaged by another device 1
Torn material 1
Positioning Issue 1
Difficult to position 1
Loss of power 1
Prep, failure to 1
Material puncture 1
R on T phenomenon 1
Occlusion within device 1
Overheating of device or device component 1
Device inoperable 1
Use of Device Issue 1
Failure to read input signal 1
Smoking 1
Restricted flowrate 1
Hole in material 1
Device alarm system issue 1
Artifact 1
Degraded 1
Total Device Problems 681

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

-
-