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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device clamp, vascular
Regulation Description Vascular clamp.
Product CodeDXC
Regulation Number 870.4450
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ADVANCED VASCULAR DYNAMICS
  SUBSTANTIALLY EQUIVALENT 6
AESCULAP
  SUBSTANTIALLY EQUIVALENT 1
APPLIED MEDICAL RESOURCES CORP.
  SUBSTANTIALLY EQUIVALENT 3
BAXTER HEALTHCARE CORP.
  SUBSTANTIALLY EQUIVALENT 1
BENTLEY LABORATORIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
BIOVASCULAR INC
  SUBSTANTIALLY EQUIVALENT 3
BOSS INSTRUMENTS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
CARDINAL HEALTH
  SUBSTANTIALLY EQUIVALENT 3
CARDIVA MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 7
CORDIS CORP.
  SUBSTANTIALLY EQUIVALENT 1
DATASCOPE CORP.
  SUBSTANTIALLY EQUIVALENT 2
DEGANIA SILICONE, LTD.
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 3
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 2
HEARTPORT, INC.
  SUBSTANTIALLY EQUIVALENT 5
HEBUMEDICAL
  SUBSTANTIALLY EQUIVALENT 1
IMPLANTABLE DEVICES
  SUBSTANTIALLY EQUIVALENT 1
INNOVASA, INC.
  SUBSTANTIALLY EQUIVALENT 1
KARL STORZ GMBH & CO. KG
  SUBSTANTIALLY EQUIVALENT 2
MARINE POLYMER TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MCPHERSON ENTERPRISES, INC.
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 1
NONE
  SUBSTANTIALLY EQUIVALENT 1
NOVARE SURGICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 6
PILLING WECK
  SUBSTANTIALLY EQUIVALENT 1
PRESSURE PRODUCTS, INC.
  SUBSTANTIALLY EQUIVALENT 1
RADI MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 8
SEMLER TECHNOLOGIES, INC. DBA
  SUBSTANTIALLY EQUIVALENT 1
SURGICAL INSTRUMENTS BELGIUM SA
  SUBSTANTIALLY EQUIVALENT 1
T. KOROS SURGICAL
  SUBSTANTIALLY EQUIVALENT 1
TERUMO CARDIOVASCULAR SYSTEMS
  SUBSTANTIALLY EQUIVALENT 2
TZ MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
UNITED STATES SURGICAL
  SUBSTANTIALLY EQUIVALENT 2
VASCULAR CONTROL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 4
VASCULAR SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 3
VASCUTEK LTD.
  SUBSTANTIALLY EQUIVALENT 1
W. LORENZ SURGICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Fitting problem 520
Failure to deploy 249
Crack 89
Other (for use when an appropriate device code cannot be identified) 61
Mechanical issue 41
Detachment of device component 30
Failure to advance 22
Unraveled material 20
Device operates differently than expected 18
Break 17
Foreign material present in device 15
No Known Device Problem 15
Deflation issue 14
Balloon rupture 13
No Information 13
Air leak 12
Bent 12
Leak 12
Misfire 12
Material separation 10
Material rupture 9
Fluid leak 8
Performance 7
Suction issue 7
Device Issue 6
Slippage of device or device component 5
Decrease in pressure 5
Migration of device or device component 5
Difficult to deploy 5
Device disinfection or sterilization issue 5
Pressure issue 5
Material integrity issue 5
Defective item 5
Failure to fire 4
Balloon burst 4
Balloon leak(s) 4
Source, leak(s) from 4
Failure to unfold or unwrap 4
Dull 4
Use of Device Issue 3
Device, or device fragments remain in patient 3
Balloon asymmetrical 3
Premature deployment 3
Failure to fold 3
Loose or intermittent connection 3
Failure to deliver 3
Deployment issue 2
Leaflet disruption due to suture abrasion 2
Packaging issue 2
Positioning Issue 2
Device packaging compromised 2
Hole in material 2
Device Difficult to Setup or Prepare 2
Normal 2
Occlusion within device 2
Misassembled 2
Failure to Adhere or Bond 2
Contamination during use 2
Collapse 2
Sticking 2
Tip breakage 2
User used incorrect product for intended use 2
Tear, rip or hole in device packaging 2
Defective component 2
Seal, defective 2
Component missing 2
Valve(s), defective 1
Unknown (for use when the device problem is not known) 1
Material perforation 1
Failure to disconnect 1
Patch test, abnormal results of 1
Structural problem 1
Failure to align 1
Self-activation or keying 1
Inadequate training 1
Transducer overheating 1
Source, detachment from 1
Improper or incorrect procedure or method 1
Component falling 1
Failure to deliver countershock 1
Burst 1
Device Cleaning Issue 1
Misconnection 1
Mineralization 1
Particulates 1
Inflation issue 1
Kinked 1
Incorrect measurement 1
Material discolored 1
Difficult to open or close 1
Improper flow or infusion 1
Material deformation 1
Mechanical jam 1
Mechanics altered 1
Failure to cut 1
Malposition of device 1
Application program issue 1
Computer operating system issue 1
Protective measure issue 1
Total Device Problems 1390

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 1 0 1 0 0 0 0 0
Class II 0 0 1 0 1 0 0 1 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Applied Medical Resources Corp II Aug-11-2011
2 Edwards Lifesciences Research Medical, Inc. I Nov-06-2009
3 Edwards Lifesciences Research Medical, Inc. II Jan-05-2009
4 Edwards Lifesciences, LLC II Jun-11-2015
5 Maquet Cardiovascular, LLC I Feb-01-2011
6 Sam Medical Products II Dec-16-2014

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