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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, steerable
Regulation Description Steerable catheter.
Product CodeDRA
Regulation Number 870.1280
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 2
CARDIOFOCUS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CRYOCATH TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
EKOS CORP.
  SUBSTANTIALLY EQUIVALENT 1
EVALVE INC
  SUBSTANTIALLY EQUIVALENT 4
HANSEN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
HANSON MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Air leak 96
Not Applicable 92
No Known Device Problem 65
No code available 49
Leak 43
Fluid leak 36
Detachment of device component 17
No Information 12
Mislabeled 10
Difficult to remove 10
Unstable 10
Break 9
Difficult to insert 7
Device operates differently than expected 7
Material integrity issue 5
Torn material 5
Aspiration issue 4
Failure to advance 3
Physical resistance 3
Loss of or failure to bond 3
Kinked 2
Device displays error message 2
Slippage of device or device component 2
Difficult to position 2
Detachment of device or device component 2
Positioning Issue 1
Device Difficult to Setup or Prepare 1
Material separation 1
Use of Device Issue 1
Improper or incorrect procedure or method 1
Suction issue 1
Obstruction within device 1
Tip breakage 1
Device or device component damaged by another device 1
Difficult to advance 1
Dislodged or dislocated 1
High impedance 1
Hole in material 1
Occlusion within device 1
Peeled 1
Loose or intermittent connection 1
Mechanical issue 1
Balloon rupture 1
Bent 1
Contamination during use 1
Crack 1
Deflation issue 1
Total Device Problems 518

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 1 0 0 1 1 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Greatbatch Medical II Sep-26-2012
2 Hansen Medical Inc II Sep-11-2008
3 Medtronic Inc. Cardiac Rhythm Disease Management II Sep-12-2011

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