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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 2
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 523
Failure to deploy 249
Crack 89
Other (for use when an appropriate device code cannot be identified) 61
Air leak 45
Mechanical issue 42
Detachment of device component 33
Failure to advance 22
Unraveled material 20
Break 19
Leak 19
Device operates differently than expected 19
No Known Device Problem 19
Foreign material present in device 16
Deflation issue 16
Balloon rupture 13
No Information 13
Misfire 12
Bent 12
Material rupture 10
Material separation 10
Fluid leak 8
Performance 7
Suction issue 7
Device Issue 6
Migration of device or device component 6
Difficult to deploy 5
Slippage of device or device component 5
Decrease in pressure 5
Defective item 5
Material integrity issue 5
Device disinfection or sterilization issue 5
Pressure issue 5
Failure to fire 4
Failure to unfold or unwrap 4
Use of Device Issue 4
Source, leak(s) from 4
Dull 4
Balloon burst 4
Balloon leak(s) 4
Hole in material 4
Inflation issue 3
Loose or intermittent connection 3
Failure to fold 3
Premature deployment 3
Misconnection 3
Balloon asymmetrical 3
Failure to Adhere or Bond 3
Structural problem 3
Failure to deliver 3
Device, or device fragments remain in patient 3
Misassembled 2
User used incorrect product for intended use 2
Sticking 2
Tip breakage 2
Improper or incorrect procedure or method 2
Tear, rip or hole in device packaging 2
Defective component 2
Seal, defective 2
Component missing 2
Contamination during use 2
Collapse 2
Normal 2
Occlusion within device 2
Device Difficult to Setup or Prepare 2
Leaflet disruption due to suture abrasion 2
Deployment issue 2
Device packaging compromised 2
Packaging issue 2
Positioning Issue 2
Protective measure issue 1
Difficult to open or close 1
Mechanical jam 1
Mechanics altered 1
Improper flow or infusion 1
Material deformation 1
Failure to cut 1
Failure to disconnect 1
Malposition of device 1
Application program issue 1
Computer operating system issue 1
Mineralization 1
Particulates 1
Material discolored 1
Incorrect measurement 1
Kinked 1
Component falling 1
Failure to deliver countershock 1
Burst 1
Device Cleaning Issue 1
Valve(s), defective 1
Unknown (for use when the device problem is not known) 1
Material perforation 1
Failure to align 1
Patch test, abnormal results of 1
Inadequate training 1
Transducer overheating 1
Source, detachment from 1
Self-activation or keying 1
Total Device Problems 1460

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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