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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device wire, guide, catheter
Regulation Description Catheter guide wire.
Product CodeDQX
Regulation Number 870.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 17
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 45
AGA MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 8
ASAHI
  SUBSTANTIALLY EQUIVALENT 27
ASHITAKA FACTORY OF TERUMO CORP.
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 2
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOCOMPATIBLES, INC.
  SUBSTANTIALLY EQUIVALENT 2
BIOSPHERE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 5
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 54
BRIDGEPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 6
BRIVANT, LTD.
  SUBSTANTIALLY EQUIVALENT 9
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 12
CARDIMA, INC.
  SUBSTANTIALLY EQUIVALENT 1
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 15
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 29
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 10
ELCAM MEDICAL A.C.A.L.
  SUBSTANTIALLY EQUIVALENT 1
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 2
FLOWCARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 2
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 4
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 27
INTRALUMINAL THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 10
JOMED
  SUBSTANTIALLY EQUIVALENT 3
KENSEY NASH CORP.
  SUBSTANTIALLY EQUIVALENT 1
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 38
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEADOX
  SUBSTANTIALLY EQUIVALENT 3
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 2
MEDICAL DEVICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDRAD, INC.
  SUBSTANTIALLY EQUIVALENT 3
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 12
MENNEN MEDICAL LTD.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 14
MICRO THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 6
MICROVENA
  SUBSTANTIALLY EQUIVALENT 8
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICRUS
  SUBSTANTIALLY EQUIVALENT 3
NEO METRICS, INC.
  SUBSTANTIALLY EQUIVALENT 7
NIPRO CORP
  SUBSTANTIALLY EQUIVALENT 2
OSCOR, INC.
  SUBSTANTIALLY EQUIVALENT 1
OVALUM LTD.
  SUBSTANTIALLY EQUIVALENT 1
QUEST MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
RADIUS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 3
SCIMED
  SUBSTANTIALLY EQUIVALENT 32
SENTREHEART INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 4
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 8
TELEFLEX MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 11
THEROX, INC.
  SUBSTANTIALLY EQUIVALENT 1
TORAY INDUSTRIES, INC
  SUBSTANTIALLY EQUIVALENT 3
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 597
Detachment of device component 506
Difficult to remove 484
Source, detachment from 418
Peeled 395
Fracture 294
Stretched 286
Wire(s), breakage of 271
Entrapment of device or device component 247
No Known Device Problem 228
Material separation 219
Detachment of device or device component 213
Unraveled material 211
Device, or device fragments remain in patient 190
Kinked 187
Use of Device Issue 187
Failure to advance 150
Tip breakage 142
Physical resistance 130
Difficult to position 94
Other (for use when an appropriate device code cannot be identified) 93
Unknown (for use when the device problem is not known) 93
Device damaged prior to use 81
Flaked 56
Tears, rips, holes in device, device material 51
Material frayed 50
Device or device component damaged by another device 49
Difficult to insert 47
Sticking 45
Material integrity issue 45
Material fragmentation 43
Bent 42
Material deformation 39
Improper or incorrect procedure or method 38
Difficult to advance 30
Foreign material present in device 28
Device operates differently than expected 24
Leak 23
Device or device fragments location unknown 22
Positioning Issue 21
Steering wire problem 20
Out-of-box failure 19
Blockage within device or device component 19
Mislabeled 18
Foreign material 17
Uncoiled 16
Device, removal of (non-implant) 16
Migration of device or device component 15
Method, improper/incorrect 14
Split 14
Defective item 13
Occlusion within device 13
Performance 12
Crack 12
Buckled material 11
Device Issue 10
Unable to obtain readings 10
No Information 10
No code available 9
Dislodged or dislocated 9
Component(s), broken 9
Material perforation 8
Delamination 8
Device misassembled during manufacturing or shipping 8
Cut in material 8
Device markings issue 7
Obstruction within device 6
Dissection 6
Interference 6
Material Protrusion 6
Torn material 6
Material Distortion 5
Device Difficult to Setup or Prepare 5
Hole in material 5
Device displays error message 5
Tear, rip or hole in device packaging 5
Tracking 5
Sterility 5
Catheter withdrawal interference 4
Fluid leak 4
Biofilm coating in device 4
Resistance, inadequate 4
Retraction problem 4
No flow 4
Scratched material 4
Infusion or flow issue 3
Material torqued 3
Material twisted 3
Material puncture 3
No device output 3
Looping 3
Loose 3
Device expiration issue 3
Failure to deliver 3
Failure to zero 3
Defective component 3
Seal, defective 2
Component missing 2
Transducer overheating 2
Incorrect or inadequate test results 2
Total Device Problems 6828

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 1 1 0 0
Class II 0 4 4 4 5 2 3 1 5 1
Class III 2 1 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular II Jul-12-2011
2 Abbott Vascular, Inc. II Dec-20-2013
3 Argon Medical Devices, Inc II May-26-2009
4 Argon Medical Devices, Inc II Jan-31-2008
5 Arrow International Inc II Feb-17-2011
6 Arrow International Inc II Sep-25-2010
7 Baylis Medical Corp * II Dec-01-2015
8 Baylis Medical Corp * II Apr-13-2015
9 Boston Scientific III Mar-21-2007
10 Boston Scientific Corporation II Apr-12-2016
11 Boston Scientific Corporation II Aug-23-2011
12 Boston Scientific Corporation II Jan-07-2011
13 Boston Scientific Corporation II Jul-22-2010
14 Boston Scientific Corporation II Jun-04-2010
15 Boston Scientific Corporation II Jun-24-2009
16 Boston Scientific Corporation III Oct-02-2008
17 Boston Scientific Corporation II Sep-21-2008
18 Boston Scientific Target III Dec-05-2007
19 Cook, Inc. II Feb-06-2008
20 Cordis Corporation II Jan-13-2010
21 EXP Pharmaceutical Services Corp II Jul-24-2015
22 Medical Components, Inc dba MedComp II Sep-16-2008
23 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-28-2013
24 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-28-2013
25 Medtronic Vascular I Nov-15-2013
26 Merit Medical Systems, Inc. II Jun-26-2015
27 Merit Medical Systems, Inc. II Apr-22-2014
28 Nipro Medical Corporation II Oct-25-2012
29 Nitinol Devices and Components, Inc. I Jun-25-2014
30 St. Jude Medical II Sep-18-2009
31 St. Jude Medical II Aug-17-2009
32 Terumo Medical Corporation II Jul-20-2011
33 Volcano Corporation II Jun-25-2015
34 Volcano Corporation II Feb-01-2012

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