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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 39
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 1
MAXXIM MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
MEADOX
  SUBSTANTIALLY EQUIVALENT 3
MEDCOMP
  SUBSTANTIALLY EQUIVALENT 4
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 5
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 659
Detachment of device component 585
Difficult to remove 505
Peeled 466
Source, detachment from 418
Fracture 354
Stretched 294
Entrapment of device or device component 278
No Known Device Problem 276
Wire(s), breakage of 273
Material separation 241
Unraveled material 222
Detachment of device or device component 221
Kinked 197
Device, or device fragments remain in patient 191
Use of Device Issue 189
Failure to advance 154
Tip breakage 142
Physical resistance 140
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 85
Flaked 62
Material fragmentation 55
Material integrity issue 53
Material frayed 52
Device or device component damaged by another device 52
Tears, rips, holes in device, device material 51
Material deformation 51
Difficult to insert 50
Sticking 45
Bent 43
Improper or incorrect procedure or method 41
Occlusion within device 39
Difficult to advance 31
Foreign material present in device 30
Positioning Issue 26
Device operates differently than expected 25
Device or device fragments location unknown 24
Leak 23
Blockage within device or device component 23
Uncoiled 20
Steering wire problem 20
Out-of-box failure 19
Mislabeled 18
Foreign material 17
Device, removal of (non-implant) 16
Buckled material 15
Migration of device or device component 15
Method, improper/incorrect 14
Split 14
Defective item 13
Crack 13
Performance 12
Cut in material 11
No Information 11
No code available 10
Device misassembled during manufacturing or shipping 10
Device Issue 10
Unable to obtain readings 10
Component(s), broken 9
Delamination 9
Dislodged or dislocated 9
Material Protrusion 8
Material perforation 8
Retraction problem 7
Device markings issue 7
Obstruction within device 6
Dissection 6
Interference 6
Material twisted 6
Torn material 6
Scratched material 5
Material Distortion 5
Device Difficult to Setup or Prepare 5
Hole in material 5
Device displays error message 5
Sterility 5
Tracking 5
Tear, rip or hole in device packaging 5
Catheter withdrawal interference 4
Device packaging compromised 4
Deployment issue 4
Patient-device incompatibility 4
Fluid leak 4
Biofilm coating in device 4
Resistance, inadequate 4
Material torqued 4
No flow 4
Infusion or flow issue 3
Material puncture 3
No device output 3
Looping 3
Loose 3
Collapse 3
Device expiration issue 3
Failure to deliver 3
Defective component 3
Failure to zero 3
Total Device Problems 7408

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 1 1 0 3
Class II 0 4 4 4 5 2 3 1 5 3
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 Sep-07-2016
6 Arrow International Inc II Jul-12-2016
7 Arrow International Inc II Feb-17-2011
8 Arrow International Inc II Sep-25-2010
9 Baylis Medical Corp * II Dec-01-2015
10 Baylis Medical Corp * II Apr-13-2015
11 Boston Scientific III Mar-21-2007
12 Boston Scientific Corporation II Apr-12-2016
13 Boston Scientific Corporation II Aug-23-2011
14 Boston Scientific Corporation II Jan-07-2011
15 Boston Scientific Corporation II Jul-22-2010
16 Boston Scientific Corporation II Jun-04-2010
17 Boston Scientific Corporation II Jun-24-2009
18 Boston Scientific Corporation III Oct-02-2008
19 Boston Scientific Corporation II Sep-21-2008
20 Boston Scientific Target III Dec-05-2007
21 Cook Inc. I Aug-25-2016
22 Cook, Inc. II Feb-06-2008
23 Cordis Corporation II Jan-13-2010
24 EXP Pharmaceutical Services Corp II Jul-24-2015
25 Medical Components, Inc dba MedComp II Sep-16-2008
26 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-28-2013
27 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-28-2013
28 Medtronic Vascular I Nov-15-2013
29 Merit Medical Systems, Inc. II Jun-26-2015
30 Merit Medical Systems, Inc. II Apr-22-2014
31 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
32 Nipro Medical Corporation II Oct-25-2012
33 Nitinol Devices and Components, Inc. I Jun-25-2014
34 SentreHeart Inc I Nov-09-2016
35 St. Jude Medical II Sep-18-2009
36 St. Jude Medical II Aug-17-2009
37 Terumo Medical Corporation II Jul-20-2011
38 Volcano Corporation II Jun-25-2015
39 Volcano Corporation II Feb-01-2012

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