• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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
22 20 31 45 57 38 63 85 85 51

Device Problems
No Known Device Problem 86
No Information 50
Device operates differently than expected 46
Device displays error message 43
No code available 32
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 14
Noise, Audible 11
Scratched material 11
Mechanical issue 11
Sticking 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
Defective item 6
Unknown (for use when the device problem is not known) 6
Device contamination with blood or blood product 5
Catheter withdrawal interference 5
Power source issue 5
Entrapment of device or device component 5
Difficult to remove 5
Kinked 5
Peeled 4
Overheating of device or device component 4
Shock, electrical 4
Device packaging compromised 4
Dislodged or dislocated 4
Failure to shut off 4
Torn material 4
Material deformation 4
Protective measure issue 4
Material perforation 4
Use of Device Issue 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
Difficult to position 3
Moisture damage 3
Lead(s), shock from 3
Leak 3
Unintended system motion 2
Unsealed device packaging 2
Failure to power-up 2
Prep, failure to 2
Material puncture 2
Radio signal problem 2
Unable to obtain readings 2
Failure to read input signal 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
Patient-device incompatibility 2
Communication or transmission issue 2
Device inoperable 2
Retraction problem 2
Material rigid or stiff 2
Self-activation or keying 2
Therapeutic or diagnostic output failure 2
Impedance issue 2
Infusion or flow issue 2
Pressure issue 2
Output issue 2
Material twisted 2
Mechanical jam 2
Item contaminated during manufacturing or shipping 1
Device sensing issue 1
Difficult to advance 1
Unintended movement 1
Not Applicable 1
Failure to zero 1
Insufficient flow or underinfusion 1
Tear, rip or hole in device packaging 1
Device damaged prior to use 1
Low impedance 1
Computer operating system issue 1
Total Device Problems 724

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 1 2 2 3 0 0 1 1 0
Class III 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

-
-