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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 5

Device Problems
No Known Device Problem 292
No code available 55
Difficult to remove 38
Break 27
No Information 25
Temperature issue 14
Device operates differently than expected 14
Entrapment of device or device component 14
Detachment of device component 13
Foreign material present in device 13
Not Applicable 10
Kinked 10
Material separation 10
Mechanical issue 9
Device displays error message 7
Positioning Issue 7
Leak 6
Bent 6
Artifact 5
Fluid leak 5
Fracture 5
Difficult to position 5
Sticking 5
Wire(s), breakage of 5
Device inoperable 4
Use of Device Issue 4
Electrical issue 4
Knotted 4
Charred 4
Contamination during use 4
No display or display failure 4
Degraded 4
Detachment of device or device component 4
Material deformation 4
Material twisted 4
Packaging issue 3
Defective item 3
Noise, Audible 3
Device alarm system issue 3
Crack 3
Material frayed 3
Unable to obtain readings 3
Device remains activated 3
Inadequate storage 3
Out-of-box failure 3
Material perforation 3
Device damaged prior to use 3
Output above specifications 2
Image display error 2
Failure to capture 2
Failure to deploy 2
Torn material 2
Communication or transmission issue 2
Connection issue 2
Deployment issue 2
Impedance issue 2
Improper flow or infusion 2
Infusion or flow issue 2
Device packaging compromised 2
Difficult to open or close 2
Item contaminated during manufacturing or shipping 2
Manufacturing or shipping issue associated with device 1
Dislodged or dislocated 1
Failure to shut off 1
Mechanical jam 1
Material Protrusion 1
Output below specifications 1
Output issue 1
Programming issue 1
Scratched material 1
Therapeutic or diagnostic output failure 1
Device sensing issue 1
Device-device incompatibility 1
Device or device component damaged by another device 1
Issue with displayed error message 1
Device or device fragments location unknown 1
Wrinkled 1
Malposition of device 1
Patient-device incompatibility 1
Capturing issue 1
No pacing 1
Disconnection 1
Erratic display 1
Incorrect display 1
Use of Incorrect Control Settings 1
Collapse 1
Air leak 1
Excess flow or overinfusion 1
Difficult to insert 1
Material invagination 1
High impedance 1
Hole in material 1
Electrode(s), failure of 1
Foreign material 1
Overheating of device or device component 1
Migration of device or device component 1
Nonstandard device or device component 1
Normal 1
Improper or incorrect procedure or method 1
Insufficient flow or underinfusion 1
Total Device Problems 747

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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