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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
ARGON MEDICAL DEVICES INC.
  SUBSTANTIALLY EQUIVALENT 1
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 8
ASAHI
  SUBSTANTIALLY EQUIVALENT 29
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 55
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 18
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 5
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
WILLIAM COOK
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 717
Detachment of device component 657
Difficult to remove 526
Peeled 502
Source, detachment from 418
Fracture 390
No Known Device Problem 327
Entrapment of device or device component 324
Stretched 296
Wire(s), breakage of 273
Material separation 271
Unraveled material 238
Detachment of device or device component 236
Kinked 209
Device, or device fragments remain in patient 191
Use of Device Issue 189
Failure to advance 156
Physical resistance 147
Tip breakage 142
Difficult to position 96
Device damaged prior to use 94
Other (for use when an appropriate device code cannot be identified) 93
Unknown (for use when the device problem is not known) 93
Flaked 72
Material fragmentation 68
Material deformation 63
Material integrity issue 62
Device or device component damaged by another device 55
Bent 54
Material frayed 53
Difficult to insert 51
Tears, rips, holes in device, device material 51
Sticking 45
Occlusion within device 44
Improper or incorrect procedure or method 41
Difficult to advance 34
Foreign material present in device 34
Positioning Issue 34
Device operates differently than expected 30
Device or device fragments location unknown 24
Uncoiled 23
Leak 23
Blockage within device or device component 23
Buckled material 20
Steering wire problem 20
Out-of-box failure 19
Mislabeled 18
Foreign material 17
Device, removal of (non-implant) 16
Split 15
Migration of device or device component 15
Method, improper/incorrect 14
Crack 14
Delamination 14
Defective item 13
No Information 13
Material Protrusion 12
Cut in material 12
Performance 12
Device misassembled during manufacturing or shipping 11
No code available 11
Dislodged or dislocated 10
Unable to obtain readings 10
Collapse 10
Device Issue 10
Device markings issue 10
Material perforation 9
Component(s), broken 9
Material Distortion 9
Torn material 8
Retraction problem 7
Obstruction within device 6
Dissection 6
Interference 6
Material twisted 6
Material torqued 5
Scratched material 5
Device Difficult to Setup or Prepare 5
Hole in material 5
Tear, rip or hole in device packaging 5
Device displays error message 5
Sterility 5
Tracking 5
Defective component 4
Resistance, inadequate 4
Catheter withdrawal interference 4
Patient-device incompatibility 4
Deployment issue 4
Fluid leak 4
Biofilm coating in device 4
No flow 4
Device packaging compromised 4
Human-Device Interface Issue 3
Infusion or flow issue 3
Coiled 3
Device expiration issue 3
Material puncture 3
No device output 3
Looping 3
Loose 3
Total Device Problems 7951

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 1 1 0 3 0
Class II 0 4 4 4 5 2 3 1 5 3 1
Class III 2 1 0 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 Jun-12-2017
6 Arrow International Inc II Sep-07-2016
7 Arrow International Inc II Jul-12-2016
8 Arrow International Inc II Feb-17-2011
9 Arrow International Inc II Sep-25-2010
10 Baylis Medical Corp * II Dec-01-2015
11 Baylis Medical Corp * II Apr-13-2015
12 Boston Scientific III Mar-21-2007
13 Boston Scientific Corporation II Apr-12-2016
14 Boston Scientific Corporation II Aug-23-2011
15 Boston Scientific Corporation II Jan-07-2011
16 Boston Scientific Corporation II Jul-22-2010
17 Boston Scientific Corporation II Jun-04-2010
18 Boston Scientific Corporation II Jun-24-2009
19 Boston Scientific Corporation III Oct-02-2008
20 Boston Scientific Corporation II Sep-21-2008
21 Boston Scientific Target III Dec-05-2007
22 Cook Inc. I Aug-25-2016
23 Cook, Inc. II Feb-06-2008
24 Cordis Corporation II Jan-13-2010
25 EXP Pharmaceutical Services Corp II Jul-24-2015
26 Medical Components, Inc dba MedComp II Sep-16-2008
27 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-28-2013
28 Medtronic Inc. Cardiac Rhythm Disease Management II Mar-28-2013
29 Medtronic Vascular I Nov-15-2013
30 Merit Medical Systems, Inc. II Jun-26-2015
31 Merit Medical Systems, Inc. II Apr-22-2014
32 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
33 Nipro Medical Corporation II Oct-25-2012
34 Nitinol Devices and Components, Inc. I Jun-25-2014
35 SentreHeart Inc I Nov-09-2016
36 St. Jude Medical II Sep-18-2009
37 St. Jude Medical II Aug-17-2009
38 Terumo Medical Corporation II Jul-20-2011
39 Volcano Corporation II Jun-25-2015
40 Volcano Corporation II Feb-01-2012

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