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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 2017
14 8 9 12 21 19 30 25 24 47 0

Device Problems
Detachment of device component 189
No Known Device Problem 156
Leak 98
Device operates differently than expected 48
Kinked 21
Break 18
Temperature issue 16
Bent 15
Charred 12
Difficult to remove 8
No Information 8
Material separation 6
Component(s), broken 6
Fluid leak 6
Crack 5
Material discolored 4
High impedance 4
Inadequate storage 4
Device displays error message 4
Device packaging compromised 4
Device sensing issue 3
Material frayed 3
Burn of device or device component 3
Electrical issue 2
Fracture 2
Inability to irrigate 2
Loose or intermittent connection 2
Mechanical issue 2
Occlusion within device 2
Unsealed device packaging 2
Device damaged prior to use 2
Tear, rip or hole in device packaging 2
Cut in material 2
Device remains activated 2
Difficult or delayed activation 2
Noise, Audible 2
No code available 1
Torn material 1
Communication or transmission issue 1
Device or device component damaged by another device 1
Positioning Issue 1
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
Issue with displayed error message 1
Material deformation 1
Material Protrusion 1
Difficult to position 1
Loss of power 1
Prep, failure to 1
Material puncture 1
R on T phenomenon 1
No device output 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 703

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 1 0 0
Class II 0 0 0 1 0 1 2 1 1 0 0
Class III 0 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

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