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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, percutaneous
Regulation Description Percutaneous catheter.
Product CodeDQY
Regulation Number 870.1250
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 4
ACUMEN, INC.
  SUBSTANTIALLY EQUIVALENT 3
ADVANCED CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 19
AGA MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 9
ALIMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 11
ASAHI
  SUBSTANTIALLY EQUIVALENT 13
ATRIUM MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 3
AXIOM
  SUBSTANTIALLY EQUIVALENT 1
B. BRAUN MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BAYLIS MEDICAL CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOCOMPATIBLES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT - KIT 1
  SUBSTANTIALLY EQUIVALENT 17
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 37
BRIDGEPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 7
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 17
CANDELA CORP.
  SUBSTANTIALLY EQUIVALENT 2
CARDIMA, INC.
  SUBSTANTIALLY EQUIVALENT 3
CARDIOVASCULAR SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CLEARSTREAM TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
CODMAN & SHURTLEFF, INC.
  SUBSTANTIALLY EQUIVALENT 5
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 19
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 21
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 35
CRYOVASULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 4
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 1
DEROYAL
  SUBSTANTIALLY EQUIVALENT 1
DOW
  SUBSTANTIALLY EQUIVALENT 1
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 3
ENDOCROSS, LTD.
  SUBSTANTIALLY EQUIVALENT 3
ENDOLOGIX, INC.
  SUBSTANTIALLY EQUIVALENT 2
ENPATH MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
EV3 CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
E-Z-EM, INC.
  SUBSTANTIALLY EQUIVALENT 1
FLOWCARDIA, INC.
  SUBSTANTIALLY EQUIVALENT 4
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 18
GUIDED DELIVERY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 1
HEALTH LINE INTERNATIONAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
INTRALUMINAL THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 8
INVATEC INC
  SUBSTANTIALLY EQUIVALENT 3
ISOMEDIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOMED
  SUBSTANTIALLY EQUIVALENT 1
KANEKA CORP
  SUBSTANTIALLY EQUIVALENT 1
KENDALL
  SUBSTANTIALLY EQUIVALENT 4
KERBEROS PROXIMAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
LAKE REGION MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
LEMAITRE VASCULAR, INC
  SUBSTANTIALLY EQUIVALENT 2
LEMAITRE VASCULAR, INC.
  SUBSTANTIALLY EQUIVALENT 3
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 5
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 41
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
MICROVENA
  SUBSTANTIALLY EQUIVALENT 3
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 9
NAMIC
  SUBSTANTIALLY EQUIVALENT 1
NFOCUS NEUROMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVOSTE CORP
  SUBSTANTIALLY EQUIVALENT 1
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 12
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 9
RADIANT INNOVATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
RADIUS MEDICAL TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCIMED
  SUBSTANTIALLY EQUIVALENT 18
SENTREHEART INC.
  SUBSTANTIALLY EQUIVALENT 1
SHILEY, INC
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 10
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 17
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 2
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
THERMOPEUTIX INC.
  SUBSTANTIALLY EQUIVALENT 2
THOMAS MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 3
TRIREME MEDICAL INC
  SUBSTANTIALLY EQUIVALENT 1
USCI ANGIOGRAPHY DIVISION
  SUBSTANTIALLY EQUIVALENT 3
VASCON LLC
  SUBSTANTIALLY EQUIVALENT 3
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 16
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material rupture 999
Break 579
Balloon rupture 525
No Known Device Problem 463
Kinked 440
Retraction problem 390
Leak 339
Material separation 308
Detachment of device or device component 247
Deflation issue 216
Unraveled material 198
Difficult to remove 190
Other (for use when an appropriate device code cannot be identified) 166
Detachment of device component 161
Physical resistance 158
Fracture 132
Crack 124
Failure to advance 109
Burst 98
Out-of-box failure 96
Fluid leak 84
Device damaged prior to use 81
Entrapment of device or device component 79
Device-device incompatibility 79
No code available 72
Unknown (for use when the device problem is not known) 68
Material deformation 67
Inflation issue 63
Hole in material 60
Stretched 58
Migration of device or device component 55
Material frayed 52
Difficult to insert 49
Difficult to advance 49
Balloon burst 43
Shaft break 42
Device operates differently than expected 39
Occlusion within device 38
Foreign material present in device 36
Torn material 33
Product quality issue 33
Dissection 32
Material perforation 29
Improper or incorrect procedure or method 27
Mechanical issue 27
Peeled 26
Sticking 26
Material twisted 26
Material integrity issue 25
Bent 25
Blockage within device or device component 24
Split 24
Difficult to position 23
Device, removal of (non-implant) 23
Material fragmentation 22
No Information 21
Decoupling 20
Unsealed device packaging 20
Device, or device fragments remain in patient 20
Tear, rip or hole in device packaging 20
Obstruction within device 19
Device markings issue 19
Tears, rips, holes in device, device material 18
Material puncture 18
Device or device component damaged by another device 17
Defective item 17
Tip breakage 16
Collapse 16
Cut in material 15
Balloon leak(s) 14
Foreign material 13
Use of Device Issue 13
Sterility 13
Deflation, cause unknown 12
Packaging issue 12
Dislodged or dislocated 11
Patient-device incompatibility 10
Accessory incompatible 10
Air leak 10
Loose or intermittent connection 10
Component missing 9
Human-Device Interface Issue 9
Balloon pinhole 8
Infusion or flow issue 8
Loss of or failure to bond 8
Device expiration issue 7
Positioning Issue 7
Device or device fragments location unknown 7
Device packaging compromised 7
Connection issue 6
Deployment issue 6
Device inoperable 6
Fitting problem 6
Size incorrect for patient 6
Slippage of device or device component 5
Rupture, cause unknown 5
Difficult to deploy 5
Failure to deploy 5
Component(s), broken 5
Melted 5
Total Device Problems 7991

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 3 1 1 0 1 1 0 1
Class II 3 3 7 3 9 3 9 6 6 1
Class III 1 2 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 AGA Medical Corporation II Mar-11-2010
2 Abbott Vascular II Jul-12-2011
3 Abbott Vascular-Cardiac Therapies dba Guidant Corporation III Aug-13-2008
4 AngioScore Inc. I Jan-04-2011
5 Angiodynamics Worldwide Headquarters II Sep-19-2011
6 Applied Medical Resources Corp II Sep-25-2012
7 Arrow International Inc II Oct-16-2014
8 Arrow International Inc II Oct-14-2014
9 Arrow International Inc II Aug-14-2013
10 Arrow International Inc II Feb-17-2011
11 Arrow International Inc II Jan-12-2011
12 Arrow International Inc II Sep-25-2010
13 Arrow International Inc II Jul-07-2009
14 Arrow International Inc II Jun-24-2009
15 Bard Access Systems II Mar-13-2015
16 Bard Peripheral Vascular Inc II Apr-10-2015
17 Bard Peripheral Vascular Inc II Jun-12-2013
18 Bard Peripheral Vascular Inc II Jun-10-2013
19 Bard Peripheral Vascular Inc II Aug-02-2010
20 Boston Scientific II Oct-27-2007
21 Boston Scientific II Feb-07-2007
22 Boston Scientific Corporation II Jan-05-2016
23 Boston Scientific Corporation II Jun-25-2015
24 Boston Scientific Corporation II Mar-10-2014
25 Boston Scientific Corporation II Jan-07-2011
26 Boston Scientific Corporation II Nov-20-2009
27 Boston Scientific Corporation II Nov-13-2009
28 Boston Scientific Corporation II Jun-18-2009
29 Boston Scientific Corporation III May-07-2008
30 Boston Scientific Target III Nov-24-2007
31 Bridgepoint Medical II Jul-24-2012
32 Codman & Shurtleff, Inc. II Feb-20-2013
33 Concentric Medical Inc II Oct-09-2015
34 Concentric Medical Inc II Dec-12-2014
35 Concentric Medical Inc II Jan-08-2013
36 Cook Inc. I Feb-24-2016
37 Cook, Inc. II Mar-29-2007
38 Cordis Corporation II Oct-01-2013
39 Ev3, Inc. II Apr-23-2014
40 Ev3, Inc. I Dec-23-2010
41 Ev3, Inc. I Dec-23-2009
42 Flowcardia Inc. II Jan-24-2011
43 Medtronic CardioVascular II Jan-06-2011
44 Medtronic Inc. Cardiac Rhythm Disease Management II Jun-21-2013
45 Medtronic Inc. Cardiac Rhythm Managment II Sep-30-2008
46 Medtronic Perfusion Systems II Jul-24-2008
47 Medtronic Vascular II Jun-26-2015
48 Medtronic Vascular II Nov-13-2014
49 Medtronic Vascular, Inc. II Nov-06-2015
50 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Apr-16-2014
51 Penumbra Inc. I Oct-05-2009
52 Penumbra Inc. II Sep-24-2009
53 Penumbra Inc. I Sep-08-2009
54 Spectranetics Corporation II Aug-04-2011
55 Spectranetics Corporation II Feb-05-2008
56 St Jude Medical Inc I Feb-11-2013
57 Stryker Neurovascular II Dec-13-2013
58 Thomas Medical Products Inc II Feb-14-2011
59 Vascular Solutions, Inc. II Feb-20-2013
60 Vascular Solutions, Inc. II May-24-2012
61 Vascular Solutions, Inc. II Aug-21-2009

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