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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
ANGIOSCORE, INC.
  SUBSTANTIALLY EQUIVALENT 6
ARROW INTL., INC.
  SUBSTANTIALLY EQUIVALENT 11
ASAHI
  SUBSTANTIALLY EQUIVALENT 7
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 16
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 35
BRIDGEPOINT MEDICAL
  SUBSTANTIALLY EQUIVALENT 7
C.R. BARD, INC.
  SUBSTANTIALLY EQUIVALENT 15
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 3
CONCENTRIC MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 16
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 18
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 38
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 7
GISH BIOMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 18
GUIDED DELIVERY SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
HDC CORP.
  SUBSTANTIALLY EQUIVALENT 1
INTRALUMINAL THERAPEUTICS, INC.
  SUBSTANTIALLY EQUIVALENT 8
INVATEC INC
  SUBSTANTIALLY EQUIVALENT 3
ISOMEDIX, INC.
  SUBSTANTIALLY EQUIVALENT 1
JOMED
  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 2
MALLINCKRODT
  SUBSTANTIALLY EQUIVALENT 5
MANAN MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICAL COMPONENTS
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 38
MEGADYNE MEDICAL PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICROVENA
  SUBSTANTIALLY EQUIVALENT 3
MICROVENTION, INC.
  SUBSTANTIALLY EQUIVALENT 5
NAMIC
  SUBSTANTIALLY EQUIVALENT 1
NFOCUS NEUROMEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
NOVOSTE CORP
  SUBSTANTIALLY EQUIVALENT 1
NUMED, INC.
  SUBSTANTIALLY EQUIVALENT 12
PENUMBRA, INC.
  SUBSTANTIALLY EQUIVALENT 7
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 11
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 13
STEREOTAXIS, INC.
  SUBSTANTIALLY EQUIVALENT 2
STRYKER CORP.
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 3
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 14
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
VYGON CORP.
  SUBSTANTIALLY EQUIVALENT 1
W.L. GORE & ASSOCIATES,INC
  SUBSTANTIALLY EQUIVALENT 2

Device Problems
Material rupture 583
Balloon rupture 487
No Known Device Problem 244
Break 168
Other (for use when an appropriate device code cannot be identified) 163
Material separation 153
Difficult to remove 144
Retraction problem 123
Unraveled material 115
Leak 114
Deflation issue 107
Kinked 80
Fluid leak 73
No code available 69
Unknown (for use when the device problem is not known) 68
Crack 61
Detachment of device or device component 59
Burst 53
Detachment of device component 51
Out-of-box failure 49
Fracture 42
Shaft break 41
Balloon burst 40
Failure to advance 33
Difficult to insert 32
Dissection 31
Hole in material 31
Inflation issue 27
Material perforation 27
Device damaged prior to use 24
Entrapment of device or device component 23
Foreign material present in device 23
Device, removal of (non-implant) 22
Difficult to position 21
Decoupling 20
Physical resistance 19
Device, or device fragments remain in patient 19
Tears, rips, holes in device, device material 18
Sticking 17
Tip breakage 16
Tear, rip or hole in device packaging 16
Material deformation 15
No Information 15
Collapse 15
Balloon leak(s) 14
Migration of device or device component 14
Sterility 13
Foreign material 13
Torn material 12
Split 12
Defective item 12
Deflation, cause unknown 12
Material frayed 11
Improper or incorrect procedure or method 11
Blockage within device or device component 11
Stretched 11
Bent 11
Patient-device incompatibility 9
Unsealed device packaging 9
Use of Device Issue 8
Mechanical issue 8
Loose or intermittent connection 8
Occlusion within device 7
Difficult to advance 7
Balloon pinhole 7
Device or device fragments location unknown 6
Component missing 6
Obstruction within device 6
Dislodged or dislocated 6
Device or device component damaged by another device 6
Device operates differently than expected 6
Device packaging compromised 5
Component(s), broken 5
Cut in material 5
Packaging issue 5
Device expiration issue 5
Device-device incompatibility 5
Size incorrect for patient 5
Peeled 5
Fitting problem 4
Device markings issue 4
Slippage of device or device component 4
Dissatisfaction 4
Uncoiled 4
Material fragmentation 3
Material twisted 3
Air leak 3
Difficult to open or close 3
Difficult to flush 3
Material puncture 3
Rupture, cause unknown 3
Malfunction 3
Difficult to deploy 3
Application interface becomes non-functional or program exits abnormally 3
Incompatibility problem 3
Product quality issue 3
Dislodged 3
Aspiration issue 2
Contamination during use 2
Low impedance 2
Total Device Problems 3912

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 3 1 1 0 1
Class II 3 3 7 3 9 3 3
Class III 1 2 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 Feb-17-2011
8 Arrow International Inc II Jan-12-2011
9 Arrow International Inc II Sep-25-2010
10 Arrow International Inc II Jul-07-2009
11 Arrow International Inc II Jun-24-2009
12 Bard Peripheral Vascular Inc II Aug-02-2010
13 Boston Scientific II Oct-27-2007
14 Boston Scientific II Feb-07-2007
15 Boston Scientific Corporation II Jan-07-2011
16 Boston Scientific Corporation II Nov-20-2009
17 Boston Scientific Corporation II Nov-13-2009
18 Boston Scientific Corporation II Jun-18-2009
19 Boston Scientific Corporation III May-07-2008
20 Boston Scientific Target III Nov-24-2007
21 Bridgepoint Medical II Jul-24-2012
22 Codman & Shurtleff, Inc. II Feb-20-2013
23 Concentric Medical Inc II Jan-08-2013
24 Cook, Inc. II Mar-29-2007
25 Ev3, Inc. I Dec-23-2010
26 Ev3, Inc. I Dec-23-2009
27 Flowcardia Inc. II Jan-24-2011
28 Medtronic CardioVascular II Jan-06-2011
29 Medtronic Inc. Cardiac Rhythm Managment II Sep-30-2008
30 Medtronic Perfusion Systems II Jul-24-2008
31 Penumbra Inc. I Oct-05-2009
32 Penumbra Inc. II Sep-24-2009
33 Penumbra Inc. I Sep-08-2009
34 Spectranetics Corporation II Aug-04-2011
35 Spectranetics Corporation II Feb-05-2008
36 St Jude Medical Inc I Feb-11-2013
37 Thomas Medical Products Inc II Feb-14-2011
38 Vascular Solutions, Inc. II Feb-20-2013
39 Vascular Solutions, Inc. II May-24-2012
40 Vascular Solutions, Inc. II Aug-21-2009

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