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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, electrode recording, or probe, electrode recording
Regulation Description Electrode recording catheter or electrode recording probe.
Product CodeDRF
Regulation Number 870.1220
Device Class 2


Premarket Reviews
ManufacturerDecision
  SUBSTANTIALLY EQUIVALENT 3
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 3
BIOSENSE
  SUBSTANTIALLY EQUIVALENT 17
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 5
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 13
CARDIMA, INC.
  SUBSTANTIALLY EQUIVALENT 5
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
EP MEDSYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
EP TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 13
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 1
HARMAC MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
IRVINE SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 11
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 9
MILLAR INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PRORHYTHM
  SUBSTANTIALLY EQUIVALENT 1
SCIMED
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 17
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TZ MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
0 0 0 0 0 0 0 0 0 2 0

Device Problems
No Known Device Problem 195
No code available 36
Difficult to remove 34
No Information 25
Break 22
Temperature issue 13
Detachment of device component 12
Device operates differently than expected 11
Foreign material present in device 11
Not Applicable 10
Entrapment of device or device component 9
Mechanical issue 9
Kinked 9
Material separation 8
Positioning Issue 7
Device displays error message 7
Difficult to position 5
Sticking 5
Wire(s), breakage of 5
Artifact 5
Bent 5
Charred 4
Contamination during use 4
No display or display failure 4
Degraded 4
Fluid leak 4
Leak 4
Device inoperable 4
Use of Device Issue 4
Detachment of device or device component 4
Defective item 3
Material deformation 3
Noise, Audible 3
Device remains activated 3
Knotted 3
Inadequate storage 3
Out-of-box failure 3
Material perforation 3
Device damaged prior to use 3
Crack 3
Material frayed 3
Device alarm system issue 3
Failure to capture 2
Failure to deploy 2
Fracture 2
Electrical issue 2
Image display error 2
Output above specifications 2
Unable to obtain readings 2
Infusion or flow issue 2
Item contaminated during manufacturing or shipping 2
Material twisted 2
Torn material 2
Connection issue 2
Deployment issue 2
Difficult to open or close 2
Dislodged or dislocated 1
Failure to shut off 1
Impedance issue 1
Improper flow or infusion 1
Device or device component damaged by another device 1
Device packaging compromised 1
Device-device incompatibility 1
Wrinkled 1
Malposition of device 1
Patient-device incompatibility 1
Communication or transmission issue 1
Therapeutic or diagnostic output failure 1
Mechanical jam 1
Programming issue 1
Scratched material 1
Manufacturing or shipping issue associated with device 1
Material Protrusion 1
Output below specifications 1
Output issue 1
Packaging issue 1
Overheating of device or device component 1
Improper or incorrect procedure or method 1
Insufficient flow or underinfusion 1
Failure to read input signal 1
Steering wire problem 1
Defective component 1
Tube(s), defective 1
Solder joint failure 1
Tip breakage 1
Cut in material 1
Incorrect or inadequate test results 1
Failure to advance 1
Dent in material 1
Split 1
Difficult or delayed activation 1
Physical resistance 1
Excess flow or overinfusion 1
Difficult to insert 1
Material invagination 1
Migration of device or device component 1
Nonstandard device or device component 1
Normal 1
Electrode(s), failure of 1
Foreign material 1
Total Device Problems 587

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

Recalls
Manufacturer Recall Class Date Posted
1 Biosense Webster Inc II Aug-25-2008
2 Biosense Webster, Inc. II Apr-27-2015
3 Biosense Webster, Inc. II Mar-03-2015
4 Biosense Webster, Inc. II Jun-28-2013
5 Biosense Webster, Inc. II May-22-2012
6 Biosense Webster, Inc. III Aug-18-2011
7 Biosense Webster, Inc. II Jun-27-2011
8 Boston Scientific Corp II Dec-10-2014
9 Boston Scientific Corp II Aug-30-2008
10 Boston Scientific Corp III Aug-22-2007
11 Medtronic Inc. II Nov-02-2015
12 St Jude Medical II Nov-06-2014

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