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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 8
MILLAR INSTRUMENTS, INC.
  SUBSTANTIALLY EQUIVALENT 2
PRORHYTHM
  SUBSTANTIALLY EQUIVALENT 1
SCIMED
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 16
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 1
TZ MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 0 0 0 0 0 1

Device Problems
No Known Device Problem 150
Difficult to remove 31
No Information 25
Break 16
Temperature issue 13
Detachment of device component 11
Device operates differently than expected 11
Foreign material present in device 9
Not Applicable 9
Material separation 8
Kinked 8
Mechanical issue 8
Device displays error message 7
No code available 6
Wire(s), breakage of 5
Difficult to position 5
Sticking 5
Artifact 5
Bent 5
Contamination during use 4
Charred 4
Degraded 4
No display or display failure 4
Entrapment of device or device component 4
Device inoperable 4
Leak 4
Device remains activated 3
Use of Device Issue 3
Inadequate storage 3
Material perforation 3
Out-of-box failure 3
Defective item 3
Crack 3
Material frayed 3
Device alarm system issue 3
Noise, Audible 3
Detachment of device or device component 3
Positioning Issue 3
Torn material 2
Infusion or flow issue 2
Item contaminated during manufacturing or shipping 2
Material deformation 2
Material twisted 2
Failure to deploy 2
Knotted 2
Fracture 2
Image display error 2
Connection issue 2
Device damaged prior to use 2
Unable to obtain readings 2
Output above specifications 2
Overheating of device or device component 1
Failure to read input signal 1
Tube(s), defective 1
Tip breakage 1
Improper or incorrect procedure or method 1
Insufficient flow or underinfusion 1
Solder joint failure 1
Device packaging compromised 1
Device-device incompatibility 1
Difficult to open or close 1
Dislodged or dislocated 1
Failure to shut off 1
Cut in material 1
Failure to advance 1
Dent in material 1
Split 1
Difficult or delayed activation 1
Physical resistance 1
Wrinkled 1
Malposition of device 1
Patient-device incompatibility 1
Communication or transmission issue 1
Excess flow or overinfusion 1
Difficult to insert 1
Material invagination 1
Fluid leak 1
Foreign material 1
High impedance 1
Migration of device or device component 1
Nonstandard device or device component 1
Normal 1
Disconnection 1
Erratic display 1
Incorrect display 1
Electrical issue 1
Electrode(s), failure of 1
Air leak 1
Collapse 1
Use of Incorrect Control Settings 1
Mechanical jam 1
Material Protrusion 1
Manufacturing or shipping issue associated with device 1
Impedance issue 1
Improper flow or infusion 1
Therapeutic or diagnostic output failure 1
Programming issue 1
Scratched material 1
Output below specifications 1
Output issue 1
Total Device Problems 476

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