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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
Product CodeLQR
Regulation Number 876.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
  SUBSTANTIALLY EQUIVALENT - KIT 1
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGYCO.,LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 41 41
2020 51 51
2021 47 47
2022 58 58
2023 71 71
2024 21 21

Device Problems MDRs with this Device Problem Events in those MDRs
Break 119 119
Fracture 33 33
Material Separation 30 30
Difficult to Fold, Unfold or Collapse 20 20
Difficult to Remove 20 20
Detachment of Device or Device Component 20 20
Positioning Problem 19 19
Adverse Event Without Identified Device or Use Problem 14 14
Material Deformation 13 13
Material Rupture 11 11
Defective Device 9 9
Entrapment of Device 7 7
Mechanical Jam 6 6
Material Split, Cut or Torn 6 6
Difficult to Open or Close 4 4
Failure to Fold 4 4
Mechanical Problem 4 4
Failure to Conduct 3 3
Failure to Advance 3 3
Retraction Problem 2 2
Difficult to Advance 2 2
Material Twisted/Bent 2 2
Separation Problem 2 2
Failure to Deflate 1 1
Unintended Movement 1 1
Firing Problem 1 1
Physical Resistance/Sticking 1 1
Activation Problem 1 1
Device Dislodged or Dislocated 1 1
Material Integrity Problem 1 1
Deformation Due to Compressive Stress 1 1
Device Damaged by Another Device 1 1
Burst Container or Vessel 1 1
Material Fragmentation 1 1
Peeled/Delaminated 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Use of Device Problem 1 1
Component Missing 1 1
Tear, Rip or Hole in Device Packaging 1 1
Failure to Align 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 168 168
No Consequences Or Impact To Patient 69 69
Foreign Body In Patient 16 16
No Known Impact Or Consequence To Patient 12 12
No Code Available 11 11
Perforation 6 6
Pancreatitis 6 6
Insufficient Information 4 4
Device Embedded In Tissue or Plaque 4 4
No Patient Involvement 3 3
Gastrointestinal Hemorrhage 2 2
Hemorrhage/Bleeding 2 2
Hypoxia 2 2
Unspecified Hepatic or Biliary Problem 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Inflammation 1 1
Necrosis 1 1
Jaundice 1 1
Abdominal Pain 1 1
Erosion 1 1
Intraoperative Pain 1 1
Peritonitis 1 1
Blood Loss 1 1

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