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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 127
Inflation issue 115
Measurements, inaccurate 107
Balloon leak(s) 89
Deflation issue 74
Material rupture 58
Fluid leak 53
Incorrect measurement 35
Other (for use when an appropriate device code cannot be identified) 35
Balloon rupture 33
Break 30
Incorrect or inadequate result 29
Unable to obtain readings 21
Leak 20
Air leak 20
Contamination during use 19
No code available 18
Detachment of device component 17
Unknown (for use when the device problem is not known) 15
Low readings 15
Burst 14
Incorrect display 12
Balloon burst 11
Difficult to remove 10
Component missing 9
High Readings 8
Device operates differently than expected 8
Source, detachment from 8
Difficult to insert 7
Interlumen communication 6
Hole in material 6
Cut in material 5
Failure to sterilize 4
Kinked 4
Difficult to position 4
Crack 4
Deflation due to damage from surgical instrument 4
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
Material perforation 3
Blood in tubing 3
Defective component 3
Detachment of device or device component 3
Gas leak 3
No Known Device Problem 3
Output issue 2
Positioning Issue 2
Electrical wires, defective 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
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
Error or warning message, failure to produce 1
Drift 1
Fracture 1
Material fragmentation 1
Filter leak(s) 1
Inaccurate flowrate 1
Failure to flush 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
Mislabeled 1
Mechanical issue 1
Pacing inadequately 1
Loose 1
Markings unclear 1
Knotted 1
Rupture, fold or crease due to 1
Particulates 1
Premature deployment 1
Total Device Problems 1174

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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