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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 241
No code available 42
Difficult to remove 38
No Information 25
Break 24
Temperature issue 13
Foreign material present in device 13
Detachment of device component 12
Device operates differently than expected 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
Leak 6
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
Device inoperable 4
Use of Device Issue 4
Detachment of device or device component 4
Packaging issue 3
Material deformation 3
Defective item 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
Electrical issue 3
Crack 3
Material frayed 3
Device alarm system issue 3
Failure to capture 2
Failure to deploy 2
Fracture 2
Image display error 2
Output above specifications 2
Unable to obtain readings 2
Communication or transmission issue 2
Connection issue 2
Deployment issue 2
Device packaging compromised 2
Difficult to open or close 2
Infusion or flow issue 2
Item contaminated during manufacturing or shipping 2
Material twisted 2
Torn material 2
Therapeutic or diagnostic output failure 1
Programming issue 1
Scratched material 1
Mechanical jam 1
Output below specifications 1
Output issue 1
Manufacturing or shipping issue associated with device 1
Material Protrusion 1
Dislodged or dislocated 1
Failure to shut off 1
Impedance issue 1
Improper flow or infusion 1
Device sensing issue 1
Device-device incompatibility 1
Device or device component damaged by another device 1
Device or device fragments location unknown 1
Wrinkled 1
Malposition of device 1
Patient-device incompatibility 1
No pacing 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
Total Device Problems 654

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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