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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device biliary catheter for stone removal that may also allow for irrigation and contrast injection
Product CodeGCA
Regulation Number 876.5010
Device Class 2


Premarket Reviews
ManufacturerDecision
ANREI MEDICAL (HANGZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 38 38
2020 20 20
2021 8 8
2022 18 18
2023 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 27 27
Material Rupture 16 16
Deflation Problem 13 13
Leak/Splash 11 11
Material Separation 10 10
Difficult to Advance 9 9
Adverse Event Without Identified Device or Use Problem 7 7
Material Fragmentation 4 4
Fracture 2 2
Improper or Incorrect Procedure or Method 2 2
Obstruction of Flow 2 2
Detachment of Device or Device Component 2 2
Device Contaminated During Manufacture or Shipping 2 2
Material Twisted/Bent 2 2
Break 2 2
Burst Container or Vessel 1 1
Positioning Failure 1 1
Use of Device Problem 1 1
Material Deformation 1 1
Migration 1 1
Physical Resistance/Sticking 1 1
Failure to Deflate 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 35 35
No Clinical Signs, Symptoms or Conditions 23 23
No Consequences Or Impact To Patient 16 16
Foreign Body In Patient 6 6
Insufficient Information 5 5
No Patient Involvement 4 4
Inflammation 3 3
Hemorrhage/Bleeding 3 3
No Code Available 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Thrombocytopenia 1 1
Pleural Empyema 1 1
Gastrointestinal Hemorrhage 1 1
Pancreatitis 1 1
Hyperbilirubinemia 1 1
Fever 1 1
Fistula 1 1
Tachycardia 1 1

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