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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 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 2

Device Problems
No Known Device Problem 167
Difficult to remove 31
No Information 25
No code available 25
Break 17
Temperature issue 13
Detachment of device component 12
Device operates differently than expected 11
Foreign material present in device 9
Not Applicable 9
Kinked 8
Mechanical issue 8
Material separation 8
Device displays error message 7
Entrapment of device or device component 7
Artifact 5
Bent 5
Wire(s), breakage of 5
Difficult to position 5
Sticking 5
Leak 4
Device inoperable 4
Contamination during use 4
Charred 4
Degraded 4
No display or display failure 4
Positioning Issue 4
Material deformation 3
Noise, Audible 3
Device alarm system issue 3
Crack 3
Knotted 3
Material frayed 3
Use of Device Issue 3
Device remains activated 3
Inadequate storage 3
Material perforation 3
Device damaged prior to use 3
Out-of-box failure 3
Defective item 3
Detachment of device or device component 3
Connection issue 2
Deployment issue 2
Unable to obtain readings 2
Output above specifications 2
Fracture 2
Image display error 2
Electrical issue 2
Failure to deploy 2
Torn material 2
Material twisted 2
Infusion or flow issue 2
Item contaminated during manufacturing or shipping 2
Manufacturing or shipping issue associated with device 1
Impedance issue 1
Improper flow or infusion 1
Device packaging compromised 1
Device-device incompatibility 1
Difficult to open or close 1
Dislodged or dislocated 1
Failure to shut off 1
Mechanical jam 1
Material Protrusion 1
Programming issue 1
Scratched material 1
Output below specifications 1
Output issue 1
Therapeutic or diagnostic output failure 1
Disconnection 1
Erratic display 1
Electrode(s), failure of 1
Incorrect display 1
Air leak 1
Collapse 1
Use of Incorrect Control Settings 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
Overheating of device or device component 1
Failure to read input signal 1
Steering wire problem 1
Tip breakage 1
Improper or incorrect procedure or method 1
Insufficient flow or underinfusion 1
Wrinkled 1
Malposition of device 1
Patient-device incompatibility 1
Communication or transmission issue 1
Solder joint failure 1
Tube(s), defective 1
Cut in material 1
Failure to advance 1
Dent in material 1
Split 1
Total Device Problems 523

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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