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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, cholangiography
Product CodeGBZ
Regulation Number 878.4200
Device Class 1

MDR Year MDR Reports MDR Events
2019 12 12
2020 11 11
2021 7 7
2022 7 7
2023 5 5
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Break 7 7
Detachment of Device or Device Component 4 4
Device Contaminated During Manufacture or Shipping 3 3
Obstruction of Flow 3 3
Material Split, Cut or Torn 3 3
Entrapment of Device 3 3
Fluid/Blood Leak 3 3
Flushing Problem 3 3
Burst Container or Vessel 2 2
Delivered as Unsterile Product 2 2
Difficult to Insert 2 2
Material Separation 2 2
Insufficient Information 2 2
Defective Device 2 2
Component Missing 2 2
Loss of or Failure to Bond 1 1
Material Deformation 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Positioning Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Misassembly by Users 1 1
Physical Resistance/Sticking 1 1
Improper or Incorrect Procedure or Method 1 1
Inadequate Instructions for Healthcare Professional 1 1
Unsealed Device Packaging 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Disconnection 1 1
Erratic or Intermittent Display 1 1
No Display/Image 1 1
Fracture 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
No Clinical Signs, Symptoms or Conditions 10 10
Insufficient Information 6 6
Pneumothorax 4 4
No Consequences Or Impact To Patient 3 3
Foreign Body In Patient 3 3
No Information 2 2
No Patient Involvement 2 2
Device Embedded In Tissue or Plaque 1 1
Low Blood Pressure/ Hypotension 1 1
Inflammation 1 1
Perforation 1 1
Pleural Effusion 1 1
No Code Available 1 1
Pancreatitis 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Atrium Medical Corporation II Dec-02-2023
2 Atrium Medical Corporation II Jun-28-2022
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