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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 79
Migration of device or device component 27
Premature deployment 26
Difficult to remove 17
Blockage within device or device component 13
Failure to expand 9
Break 8
Detachment of device or device component 8
No code available 8
Failure to deploy 5
Fracture 2
Deployment issue 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
Failure to advance 1
Malposition of device 1
Total Device Problems 214

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