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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 12

Device Problems
No Known Device Problem 93
No Information 49
Device operates differently than expected 48
Device displays error message 43
No code available 42
Break 31
Artifact 21
Foreign material present in device 19
Temperature issue 18
No display or display failure 18
Charred 16
Bent 15
Positioning Issue 15
Noise, Audible 11
Scratched material 11
Sticking 11
Mechanical issue 11
Material separation 10
High impedance 10
Hole in material 10
Human-Device Interface Issue 9
Material integrity issue 8
Material Protrusion 7
Crack 7
Device alarm system issue 6
Footswitch failure 6
Unknown (for use when the device problem is not known) 6
Defective item 6
Device contamination with blood or blood product 5
Catheter withdrawal interference 5
Difficult to remove 5
Power source issue 5
Entrapment of device or device component 5
Kinked 5
Peeled 4
Difficult to position 4
Overheating of device or device component 4
Shock, electrical 4
Material deformation 4
Protective measure issue 4
Torn material 4
Device packaging compromised 4
Dislodged or dislocated 4
Failure to shut off 4
Use of Device Issue 4
Material perforation 4
Improper or incorrect procedure or method 4
Other (for use when an appropriate device code cannot be identified) 3
Wire(s), breakage of 3
Device Issue 3
Physical resistance 3
Air leak 3
Deflation issue 3
Oversensing 3
Unsealed device packaging 3
Unable to obtain readings 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
Radio signal problem 2
Failure to read input signal 2
Retraction problem 2
Material rigid or stiff 2
Self-activation or keying 2
Intermittent continuity 2
Component falling 2
Fire 2
Electrical issue 2
Fracture 2
Grounding malfunction 2
Image display error 2
Inflation issue 2
Excess flow or overinfusion 2
Obstruction within device 2
Cut in material 2
Communication or transmission issue 2
Device inoperable 2
Patient-device incompatibility 2
Material twisted 2
Mechanical jam 2
Impedance issue 2
Infusion or flow issue 2
Not Applicable 2
Therapeutic or diagnostic output failure 2
Pressure issue 2
Output issue 2
Unintended movement 1
Item contaminated during manufacturing or shipping 1
Buckled material 1
Device or device component damaged by another device 1
Device sensing issue 1
Difficult to advance 1
Insufficient flow or underinfusion 1
Device damaged prior to use 1
Low impedance 1
Total Device Problems 748

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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