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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pancreatic stent, covered, metallic, removable
Regulation Description Pancreatic drainage stent and delivery system.
Definition To facilitate transmural endoscopic drainage of pancreatic pseudocysts
Product CodePCU
Regulation Number 876.5015
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 4

Device Problems
No Known Device Problem 62
Migration of device or device component 26
Premature deployment 20
Difficult to remove 16
Blockage within device or device component 9
Break 8
Detachment of device or device component 7
Failure to expand 7
No code available 6
Failure to deploy 5
Fracture 2
Positioning Issue 2
Occlusion within device 2
Foreign material present in device 1
Inadequate user interface 1
Detachment of device component 1
Retraction problem 1
Malposition of device 1
Total Device Problems 177

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