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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device cardiac ablation percutaneous catheter
Definition This product code pertains to cardiac ablation catheters indicated for general indications, treatment of supraventricular tachycardia (svt) and ventricular tachycardia (vt). This product code excludes ablation catheters indicated for treatment of atrial flutter [product code oad] and atrial fibrillation [product code oae].
Product CodeLPB
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
22 20 31 45 57 38 63 85 85 54 43

Device Problems
No Known Device Problem 265
No code available 70
No Information 49
Device operates differently than expected 48
Device displays error message 47
Break 33
Artifact 25
Temperature issue 25
Foreign material present in device 24
No display or display failure 21
Charred 17
Bent 16
Positioning Issue 15
Scratched material 11
Noise, Audible 11
Sticking 11
Hole in material 11
Mechanical issue 11
High impedance 10
Material separation 10
Human-Device Interface Issue 9
Material integrity issue 8
Material Protrusion 7
Difficult to remove 7
Crack 7
Device alarm system issue 6
Footswitch failure 6
Defective item 6
Unknown (for use when the device problem is not known) 6
Device contamination with blood or blood product 5
Failure to sense 5
Catheter withdrawal interference 5
Power source issue 5
Fracture 5
Entrapment of device or device component 5
Kinked 5
Restricted flowrate 4
Overheating of device or device component 4
Peeled 4
Difficult to position 4
Shock, electrical 4
Protective measure issue 4
Torn material 4
Material deformation 4
Device packaging compromised 4
Dislodged or dislocated 4
Failure to shut off 4
Improper or incorrect procedure or method 4
Physical resistance 4
Use of Device Issue 4
Material perforation 4
Wire(s), breakage of 3
Device Issue 3
Other (for use when an appropriate device code cannot be identified) 3
Device sensing issue 3
Electrical issue 3
Air leak 3
Deflation issue 3
Coagulation in device or device ingredient 3
Radio signal problem 3
Unable to obtain readings 3
Oversensing 3
Unsealed device packaging 3
Moisture damage 3
Lead(s), shock from 3
Leak 3
Delivered as unsterile product 2
Unintended system motion 2
Failure to power-up 2
Prep, failure to 2
Material puncture 2
Retraction problem 2
Material rigid or stiff 2
Self-activation or keying 2
Failure to read input signal 2
Component falling 2
Intermittent continuity 2
Fire 2
Grounding malfunction 2
Image display error 2
Inflation issue 2
Excess flow or overinfusion 2
Impedance issue 2
Infusion or flow issue 2
Output issue 2
Material twisted 2
Mechanical jam 2
Therapeutic or diagnostic output failure 2
Pressure issue 2
Not Applicable 2
Patient-device incompatibility 2
Communication or transmission issue 2
Tear, rip or hole in device packaging 2
Obstruction within device 2
Cut in material 2
Device inoperable 2
Failure to zero 1
Device stops intermittently 1
Telemetry discrepancy 1
Tip breakage 1
Total Device Problems 996

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 2 2 3 0 0 1 1 0 1
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 BioSense Webster, Inc. II Nov-19-2009
2 Biosense Webster, Inc. II Oct-27-2017
3 Biosense Webster, Inc. II Oct-27-2014
4 Biosense Webster, Inc. II Sep-12-2011
5 Boston Scientific Corp II Jan-27-2011
6 Boston Scientific Corp II Mar-17-2010
7 Boston Scientific Corp II Jan-14-2009
8 Boston Scientific Corporation II Nov-01-2010
9 Medtronic Inc. Cardiac Rhythm Disease Management II Sep-17-2015
10 St Jude Medical II Sep-16-2011
11 St. Jude Medical Cardiovascular Division II Sep-20-2008

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