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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device dislodger, stone, biliary
Regulation Description Biliary catheter and accessories.
Product CodeLQR
Regulation Number 876.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-TECH (NANJING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
OLYMPUS MEDICAL SYSTEMS CORP.
  SUBSTANTIALLY EQUIVALENT 1
SCIVITA MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZHEJIANG SOUDON MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 47 47
2022 58 58
2023 71 71
2024 69 69
2025 112 112
2026 34 34

Device Problems MDRs with this Device Problem Events in those MDRs
Break 115 115
Difficult to Fold, Unfold or Collapse 65 65
Fracture 61 61
Adverse Event Without Identified Device or Use Problem 45 45
Material Separation 44 44
Detachment of Device or Device Component 22 22
Difficult to Open or Close 20 20
Material Deformation 18 18
Material Split, Cut or Torn 15 15
Material Rupture 15 15
Difficult to Remove 13 13
Entrapment of Device 12 12
Positioning Problem 11 11
Defective Device 8 8
Deformation Due to Compressive Stress 7 7
Mechanical Jam 6 6
Failure to Fold 6 6
Failure to Deflate 5 5
Material Twisted/Bent 5 5
Mechanical Problem 5 5
Difficult to Advance 4 4
Failure to Advance 4 4
Deflation Problem 3 3
Retraction Problem 3 3
Use of Device Problem 2 2
Obstruction of Flow 2 2
Difficult or Delayed Activation 2 2
Failure to Conduct 2 2
Burst Container or Vessel 2 2
Failure to Deliver 1 1
Component Missing 1 1
Failure to Align 1 1
Device Damaged by Another Device 1 1
Material Integrity Problem 1 1
Misassembled 1 1
Unintended Movement 1 1
Product Quality Problem 1 1
Collapse 1 1
Tear, Rip or Hole in Device Packaging 1 1
Activation Problem 1 1
Physical Resistance/Sticking 1 1
Device Dislodged or Dislocated 1 1
Off-Label Use 1 1
Firing Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 354 354
Foreign Body In Patient 18 18
Pancreatitis 9 9
Perforation 5 5
Insufficient Information 4 4
No Consequences Or Impact To Patient 4 4
Peritonitis 3 3
Unspecified Hepatic or Biliary Problem 3 3
Hemorrhage/Bleeding 3 3
Gastrointestinal Hemorrhage 2 2
Perforation of Esophagus 2 2
Bowel Perforation 2 2
No Patient Involvement 2 2
Hypoxia 2 2
Device Embedded In Tissue or Plaque 2 2
Abdominal Pain 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Intraoperative Pain 1 1
Necrosis 1 1
Inflammation 1 1
Jaundice 1 1
Erosion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Incorporated II Apr-06-2026
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