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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 52 52

Device Problems MDRs with this Device Problem Events in those MDRs
Break 128 128
Fracture 35 35
Material Separation 31 31
Difficult to Fold, Unfold or Collapse 22 22
Detachment of Device or Device Component 21 21
Difficult to Remove 20 20
Positioning Problem 19 19
Material Rupture 15 15
Adverse Event Without Identified Device or Use Problem 15 15
Material Deformation 14 14
Defective Device 9 9
Difficult to Open or Close 8 8
Entrapment of Device 8 8
Material Split, Cut or Torn 7 7
Mechanical Jam 6 6
Mechanical Problem 5 5
Failure to Deflate 4 4
Failure to Fold 4 4
Failure to Advance 3 3
Failure to Conduct 3 3
Difficult to Advance 3 3
Separation Problem 2 2
Material Twisted/Bent 2 2
Retraction Problem 2 2
Deformation Due to Compressive Stress 1 1
Firing Problem 1 1
Device Dislodged or Dislocated 1 1
Deflation Problem 1 1
Collapse 1 1
Unintended Movement 1 1
Burst Container or Vessel 1 1
Activation Problem 1 1
Physical Resistance/Sticking 1 1
Off-Label Use 1 1
Product Quality Problem 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Damaged by Another Device 1 1
Use of Device Problem 1 1
Failure to Align 1 1
Component Missing 1 1
Material Fragmentation 1 1
Material Integrity Problem 1 1
Peeled/Delaminated 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 197 197
No Consequences Or Impact To Patient 69 69
Foreign Body In Patient 18 18
No Known Impact Or Consequence To Patient 12 12
No Code Available 11 11
Pancreatitis 6 6
Perforation 6 6
Insufficient Information 4 4
Device Embedded In Tissue or Plaque 4 4
No Patient Involvement 3 3
Gastrointestinal Hemorrhage 2 2
Unspecified Hepatic or Biliary Problem 2 2
Hypoxia 2 2
Hemorrhage/Bleeding 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
Blood Loss 1 1
Peritonitis 1 1
Jaundice 1 1
Erosion 1 1

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