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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 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Remove 38 38
Leak/Splash 34 34
Deflation Problem 30 30
Material Separation 27 27
Material Rupture 19 19
Material Protrusion/Extrusion 18 18
Break 17 17
Detachment Of Device Component 12 12
Burst Container or Vessel 10 10
Fluid/Blood Leak 10 10
Material Fragmentation 10 10
Adverse Event Without Identified Device or Use Problem 10 10
Difficult to Advance 9 9
Detachment of Device or Device Component 6 6
Improper or Incorrect Procedure or Method 5 5
Sticking 4 4
Fracture 4 4
Device Contaminated During Manufacture or Shipping 4 4
Obstruction of Flow 3 3
Device Operates Differently Than Expected 3 3
Component Falling 3 3
Crack 3 3
Inflation Problem 2 2
Difficult to Insert 2 2
Use of Device Problem 2 2
Tear, Rip or Hole in Device Packaging 2 2
Split 2 2
Fitting Problem 2 2
Material Twisted/Bent 2 2
Moisture or Humidity Problem 1 1
Packaging Problem 1 1
Torn Material 1 1
Appropriate Term/Code Not Available 1 1
Migration 1 1
Physical Resistance/Sticking 1 1
Failure to Deflate 1 1
Cut In Material 1 1
Device Disinfection Or Sterilization Issue 1 1
Device Markings/Labelling Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Deformation 1 1
Device Dislodged or Dislocated 1 1
Component Missing 1 1
Out-Of-Box Failure 1 1
Shelf Life Exceeded 1 1
Retraction Problem 1 1
Separation Failure 1 1
Physical Resistance 1 1
Defective Device 1 1
Device Or Device Fragments Location Unknown 1 1
Wrinkled 1 1
Inadequate Instructions for Healthcare Professional 1 1
Off-Label Use 1 1
Hole In Material 1 1
Calcified 1 1
Positioning Failure 1 1
Disassembly 1 1
Disconnection 1 1
Material Disintegration 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 28 28
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
Perforation 2 2
Device Embedded In Tissue or Plaque 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Bowel Perforation 1 1
Thrombocytopenia 1 1
Pleural Empyema 1 1
Gastrointestinal Hemorrhage 1 1
Pancreatitis 1 1
Tachycardia 1 1
Jaundice 1 1
Pain 1 1
Hyperbilirubinemia 1 1
Abscess 1 1
Fever 1 1
Fistula 1 1

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