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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 603
Detachment of device component 523
Difficult to remove 491
Source, detachment from 418
Peeled 402
Fracture 302
Stretched 287
Wire(s), breakage of 271
Entrapment of device or device component 251
No Known Device Problem 235
Material separation 221
Unraveled material 214
Detachment of device or device component 213
Kinked 192
Device, or device fragments remain in patient 190
Use of Device Issue 187
Failure to advance 152
Tip breakage 142
Physical resistance 134
Difficult to position 95
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 82
Flaked 56
Tears, rips, holes in device, device material 51
Material frayed 50
Material fragmentation 49
Device or device component damaged by another device 49
Difficult to insert 47
Sticking 45
Material integrity issue 45
Bent 42
Material deformation 40
Improper or incorrect procedure or method 38
Difficult to advance 30
Foreign material present in device 28
Device operates differently than expected 24
Positioning Issue 23
Device or device fragments location unknown 23
Leak 23
Blockage within device or device component 22
Steering wire problem 20
Out-of-box failure 19
Mislabeled 18
Foreign material 17
Occlusion within device 16
Device, removal of (non-implant) 16
Uncoiled 16
Migration of device or device component 15
Method, improper/incorrect 14
Split 14
Defective item 13
Buckled material 13
Performance 12
Crack 12
No Information 11
No code available 10
Unable to obtain readings 10
Device Issue 10
Device misassembled during manufacturing or shipping 9
Component(s), broken 9
Dislodged or dislocated 9
Delamination 8
Cut in material 8
Material perforation 8
Device markings issue 7
Obstruction within device 6
Dissection 6
Interference 6
Material Protrusion 6
Torn material 6
Material Distortion 5
Retraction problem 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
Sterility 5
Tracking 5
Resistance, inadequate 4
Catheter withdrawal interference 4
Fluid leak 4
Biofilm coating in device 4
Material twisted 4
No flow 4
Scratched material 4
Material torqued 3
Infusion or flow issue 3
Device expiration issue 3
Material puncture 3
No device output 3
Looping 3
Loose 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 6926

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

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