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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device biliary catheter for stone removal that may also allow for irrigation and contrast injection
Regulation Description Biliary catheter and accessories.
Product CodeGCA
Regulation Number 876.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
COOK ENDOSCOPY
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1
WILSON COOK MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Difficult to Remove 35
Material Separation 22
Material Protrusion/Extrusion 18
Leak/Splash 15
Deflation Problem 13
Break 9
Difficult to Advance 9
Fluid Leak 9
Material Fragmentation 9
Burst Container or Vessel 7
Detachment of Device or Device Component 6
Adverse Event Without Identified Device or Use Problem 5
Device Contaminated During Manufacture or Shipping 4
Device Operates Differently Than Expected 3
Detachment Of Device Component 3
Fracture 3
Difficult to Insert 2
Fitting Problem 2
Catheter 2
Sticking 1
Crack 1
Material Rupture 1
Unintended Ejection 1
Physical Resistance 1
Moisture or Humidity Problem 1
Calcified 1
Split 1
Wrinkled 1
Retraction Problem 1
Shelf Life Exceeded 1
Material Deformation 1
Off-Label Use 1
Obstruction of Flow 1
Separation Failure 1
Appropriate Term/Code Not Available 1
Hole In Material 1
Improper or Incorrect Procedure or Method 1
Total Device Problems 194

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015

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