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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
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT - KIT 1
HANGZHOU AGS MEDTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
WILSON-COOK MEDICAL, INC
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2014 11 11
2015 20 20
2016 14 14
2017 85 85
2018 38 38
2019 38 38
2020 20 20
2021 8 8
2022 18 18
2023 11 11
2024 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 38 38
Leak/Splash 34 34
Deflation Problem 32 32
Material Separation 27 27
Material Rupture 22 22
Material Protrusion/Extrusion 18 18
Break 17 17
Detachment Of Device Component 12 12
Fluid/Blood Leak 10 10
Material Fragmentation 10 10
Burst Container or Vessel 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Difficult to Advance 9 9
Improper or Incorrect Procedure or Method 6 6
Detachment of Device or Device Component 6 6
Device Contaminated During Manufacture or Shipping 4 4
Fracture 4 4
Sticking 4 4
Crack 3 3
Component Falling 3 3
Obstruction of Flow 3 3
Device Operates Differently Than Expected 3 3
Fitting Problem 2 2
Split 2 2
Difficult to Insert 2 2
Material Twisted/Bent 2 2
Use of Device Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Inflation Problem 2 2
Hole In Material 1 1
Calcified 1 1
Material Disintegration 1 1
Separation Failure 1 1
Physical Resistance/Sticking 1 1
Off-Label Use 1 1
Migration 1 1
Retraction Problem 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Or Device Fragments Location Unknown 1 1
Failure to Deflate 1 1
Appropriate Term/Code Not Available 1 1
Device Dislodged or Dislocated 1 1
Material Deformation 1 1
Packaging Problem 1 1
Moisture or Humidity Problem 1 1
Physical Resistance 1 1
Out-Of-Box Failure 1 1
Component Missing 1 1
Positioning Failure 1 1
Unintended Ejection 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 76 76
No Known Impact Or Consequence To Patient 75 75
No Code Available 43 43
No Clinical Signs, Symptoms or Conditions 34 34
Foreign Body In Patient 27 27
No Patient Involvement 18 18
No Information 6 6
Insufficient Information 5 5
Inflammation 4 4
Hemorrhage/Bleeding 3 3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Perforation 2 2
Device Embedded In Tissue or Plaque 2 2
Pancreatitis 1 1
Hyperbilirubinemia 1 1
Gastrointestinal Hemorrhage 1 1
Bowel Perforation 1 1
Pleural Empyema 1 1
Fever 1 1
Jaundice 1 1
Pain 1 1
Abscess 1 1
Tachycardia 1 1
Thrombocytopenia 1 1
Fistula 1 1

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015
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