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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stylet, catheter
Regulation Description Catheter stylet.
Product CodeDRB
Regulation Number 870.1380
Device Class 2


Premarket Reviews
ManufacturerDecision
ABBOTT
  SUBSTANTIALLY EQUIVALENT 1
ACCUFIX RESEARCH INSTITUTE
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
ENDOCARDIAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
GUIDANT CORP
  SUBSTANTIALLY EQUIVALENT 5
MEDTRONIC, INC.
  SUBSTANTIALLY EQUIVALENT 3
SPECTRANETICS CORP.
  SUBSTANTIALLY EQUIVALENT 2
ST. JUDE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
SYNOVIS SURGICAL INNOVATIONS
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
No code available 28
Difficult to insert 16
Difficult to position 5
Mechanical issue 4
Difficult to remove 4
Sticking 3
Device damaged prior to use 3
Mislabeled 3
Break 3
Defective component 2
Use of Device Issue 2
Other (for use when an appropriate device code cannot be identified) 2
Failure to advance 2
Defective item 2
Bent 2
No Information 2
Packaging issue 1
Structural problem 1
Device inoperable 1
Shelf life exceeded 1
Detachment of device component 1
Contamination during use 1
Material frayed 1
Device remains activated 1
Device, or device fragments remain in patient 1
Total Device Problems 92

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