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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 9

Device Problems
Detachment of device component 189
No Known Device Problem 160
Leak 98
Device operates differently than expected 55
Kinked 23
Break 23
Bent 18
Temperature issue 18
Charred 12
Difficult to remove 8
No Information 8
Material separation 7
Component(s), broken 6
Fluid leak 6
Crack 5
Device displays error message 5
Device packaging compromised 4
Device sensing issue 4
Inadequate storage 4
Material discolored 4
High impedance 4
Material frayed 3
Burn of device or device component 3
Tear, rip or hole in device packaging 3
Cut in material 2
Material puncture 2
Device remains activated 2
Difficult or delayed activation 2
Device damaged prior to use 2
Material deformation 2
Fracture 2
Electrical issue 2
Inability to irrigate 2
Loose or intermittent connection 2
Mechanical issue 2
Occlusion within device 2
Unsealed device packaging 2
Noise, Audible 2
No code available 1
Torn material 1
Difficult to position 1
Loss of power 1
Prep, failure to 1
Failure to read input signal 1
Smoking 1
Output energy incorrect 1
No device output 1
Overheating of device or device component 1
Hole in material 1
Failure to deliver energy 1
Restricted flowrate 1
Device alarm system issue 1
Artifact 1
Degraded 1
Material Protrusion 1
Positioning Issue 1
Communication or transmission issue 1
Device or device component damaged by another device 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
Low impedance 1
Defective component 1
Device contamination with blood or blood product 1
Device Issue 1
Device inoperable 1
Use of Device Issue 1
Insufficient flow or underinfusion 1
R on T phenomenon 1
Incorrect or inadequate test results 1
Split 1
Failure to disconnect 1
Total Device Problems 736

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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