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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, flow directed
Regulation Description Flow-directed catheter.
Product CodeDYG
Regulation Number 870.1240
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
  1.  K874465  SORENSON THERMO. FLOW-DIRECT TRANS PACE CATH/LEAD
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 8
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 2
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 4
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 2
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 1
HARMAC MEDICAL PRODUCTS
  SUBSTANTIALLY EQUIVALENT 1
INSTRUMENTATION LABORATORY
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 4
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Failure to pace or properly pace 149
Inflation issue 126
Measurements, inaccurate 107
Balloon leak(s) 89
Deflation issue 85
Material rupture 64
Incorrect or inadequate result 63
Fluid leak 54
Incorrect measurement 35
Other (for use when an appropriate device code cannot be identified) 35
Balloon rupture 33
Break 31
Leak 27
No code available 24
Unable to obtain readings 21
Detachment of device component 21
Air leak 20
Contamination during use 19
No Known Device Problem 18
Unknown (for use when the device problem is not known) 15
Low readings 15
Burst 15
Incorrect display 12
Balloon burst 11
Difficult to remove 11
Component missing 9
Device operates differently than expected 9
High Readings 8
Source, detachment from 8
Difficult to insert 7
Interlumen communication 6
Kinked 6
Hole in material 6
Cut in material 5
Foreign material present in device 5
Gas leak 4
Failure to sterilize 4
Difficult to position 4
Material fragmentation 4
Deflation due to damage from surgical instrument 4
Crack 4
Deflation, cause unknown 3
No display or display failure 3
Difficult to flush 3
Foreign material 3
Entrapment of device or device component 3
False reading from device non-compliance 3
Component(s), broken 3
Bleed back 3
Balloon asymmetrical 3
Occlusion within device 3
No device output 3
Unsealed device packaging 3
Material separation 3
Material perforation 3
Blood in tubing 3
Defective component 3
Detachment of device or device component 3
Deployment issue 2
Defective item 2
Material integrity issue 2
Output issue 2
Positioning Issue 2
Difficult to advance 2
Failure to expand 2
Failure to sense 2
Electrical wires, defective 2
Device Issue 2
Pressure, insufficient 2
Device damaged prior to use 2
Unstable 2
Use of Device Issue 2
Wedge, difficult to 2
Wavelength, incorrect 2
Sterility 2
Tip breakage 2
Tubing, incorrect placement of 2
Failure to read input signal 2
Rupture, cause unknown 2
Material puncture 2
Plugged 2
Material frayed 2
Mechanical issue 2
Misassembled 2
Knotted 2
Looping 2
Loose 1
Markings unclear 1
Mislabeled 1
Difficult to Program or Calibrate 1
Particulates 1
Pacing inadequately 1
Rupture, fold or crease due to 1
Bent 1
Changes in ambient temperature in device environment 1
Aspiration, excessive 1
Blockage within device or device component 1
Burn of device or device component 1
Coiled 1
Filter leak(s) 1
Total Device Problems 1314

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

Recalls
Manufacturer Recall Class Date Posted
1 Arrow International Inc II Apr-04-2013
2 B. Braun Medical, Inc. II Jul-23-2007
3 Edwards Lifesciences Technology SARL II Jan-05-2007
4 Edwards Lifesciences, LLC II Jun-02-2015
5 Edwards Lifesciences, LLC II Aug-12-2012
6 Edwards Lifesciences, Llc II Apr-17-2009

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