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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 0

Device Problems
No Known Device Problem 88
No Information 50
Device operates differently than expected 46
Device displays error message 43
No code available 35
Break 31
Artifact 21
Foreign material present in device 19
Temperature issue 18
No display or display failure 18
Charred 16
Positioning Issue 15
Bent 15
Scratched material 11
Mechanical issue 11
Noise, Audible 11
Sticking 11
Material separation 10
Hole in material 10
High impedance 10
Human-Device Interface Issue 9
Material integrity issue 8
Material Protrusion 7
Crack 7
Defective item 6
Device alarm system issue 6
Footswitch failure 6
Unknown (for use when the device problem is not known) 6
Device contamination with blood or blood product 5
Power source issue 5
Difficult to remove 5
Catheter withdrawal interference 5
Entrapment of device or device component 5
Kinked 5
Overheating of device or device component 4
Material perforation 4
Torn material 4
Failure to shut off 4
Device packaging compromised 4
Protective measure issue 4
Shock, electrical 4
Peeled 4
Material deformation 4
Improper or incorrect procedure or method 4
Use of Device Issue 4
Dislodged or dislocated 4
Deflation issue 3
Lead(s), shock from 3
Oversensing 3
Physical resistance 3
Leak 3
Device Issue 3
Air leak 3
Wire(s), breakage of 3
Difficult to position 3
Other (for use when an appropriate device code cannot be identified) 3
Moisture damage 3
Unable to obtain readings 3
Impedance issue 2
Component falling 2
Grounding malfunction 2
Cut in material 2
Output issue 2
Excess flow or overinfusion 2
Failure to power-up 2
Radio signal problem 2
Mechanical jam 2
Material rigid or stiff 2
Unsealed device packaging 2
Pressure issue 2
Image display error 2
Inflation issue 2
Infusion or flow issue 2
Material twisted 2
Communication or transmission issue 2
Fracture 2
Patient-device incompatibility 2
Fire 2
Failure to read input signal 2
Device inoperable 2
Prep, failure to 2
Retraction problem 2
Obstruction within device 2
Material puncture 2
Therapeutic or diagnostic output failure 2
Unintended system motion 2
Electrical issue 2
Intermittent continuity 2
Self-activation or keying 2
Device remains activated 1
Connection issue 1
Output above specifications 1
Delivered as unsterile product 1
Insufficient heating 1
Not Applicable 1
Cautery 1
Buckled material 1
Loss of or failure to bond 1
Looping 1
Output energy incorrect 1
Total Device Problems 731

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 0
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-27-2014
3 Biosense Webster, Inc. II Sep-12-2011
4 Boston Scientific Corp II Jan-27-2011
5 Boston Scientific Corp II Mar-17-2010
6 Boston Scientific Corp II Jan-14-2009
7 Boston Scientific Corporation II Nov-01-2010
8 Medtronic Inc. Cardiac Rhythm Disease Management II Sep-17-2015
9 St Jude Medical II Sep-16-2011
10 St. Jude Medical Cardiovascular Division II Sep-20-2008

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