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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
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 128
Inflation issue 117
Measurements, inaccurate 107
Balloon leak(s) 89
Deflation issue 75
Material rupture 59
Fluid leak 53
Incorrect measurement 35
Other (for use when an appropriate device code cannot be identified) 35
Incorrect or inadequate result 34
Balloon rupture 33
Break 31
Leak 23
Unable to obtain readings 21
Air leak 20
Contamination during use 19
No code available 18
Detachment of device component 17
Burst 15
Unknown (for use when the device problem is not known) 15
Low readings 15
Incorrect display 12
Balloon burst 11
Difficult to remove 10
Component missing 9
Device operates differently than expected 8
High Readings 8
Source, detachment from 8
Difficult to insert 7
Interlumen communication 6
Hole in material 6
No Known Device Problem 6
Cut in material 5
Kinked 5
Difficult to position 4
Crack 4
Deflation due to damage from surgical instrument 4
Failure to sterilize 4
Material perforation 3
Blood in tubing 3
Defective component 3
Detachment of device or device component 3
Foreign material present in device 3
Gas leak 3
No display or display failure 3
Deflation, cause unknown 3
Foreign material 3
Difficult to flush 3
False reading from device non-compliance 3
Component(s), broken 3
Bleed back 3
Balloon asymmetrical 3
Unsealed device packaging 3
No device output 3
Plugged 2
Sterility 2
Failure to sense 2
Material separation 2
Failure to read input signal 2
Material puncture 2
Rupture, cause unknown 2
Looping 2
Occlusion within device 2
Misassembled 2
Material frayed 2
Entrapment of device or device component 2
Material integrity issue 2
Electrical wires, defective 2
Output issue 2
Positioning Issue 2
Device Issue 2
Pressure, insufficient 2
Defective item 2
Tubing, incorrect placement of 2
Device damaged prior to use 2
Tip breakage 2
Unstable 2
Use of Device Issue 2
Wedge, difficult to 2
Wavelength, incorrect 2
Tube(s), splitting of 1
Stretched 1
Unexpected therapeutic results 1
Blood gas measurements, erroneous 1
Twisting 1
Improper or incorrect procedure or method 1
Suction issue 1
Patient-device incompatibility 1
Blocked connection 1
Communication or transmission issue 1
Connection issue 1
Structural problem 1
Failure to advance 1
Failure to obtain samples 1
Difficult or delayed activation 1
Malfunction 1
Failure to calibrate 1
Invalid sensing 1
Incomplete or missing packaging 1
Therapeutic or diagnostic output failure 1
Total Device Problems 1196

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