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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device catheter, nephrostomy
Product CodeLJE
Device Class Unclassified


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
COLOPLAST CORP
  SUBSTANTIALLY EQUIVALENT - KIT 2
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
  SUBSTANTIALLY EQUIVALENT - KIT 4
GYRUS ACMI, INC.
  SUBSTANTIALLY EQUIVALENT 1
JBW7 INNOVATIONS, LLC
  SUBSTANTIALLY EQUIVALENT 1
YOUCARE TECHNOLOGY CO., LTD. (WUHAN)
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 4 4
2015 9 9
2016 26 26
2017 60 60
2018 69 69
2019 78 78
2020 50 50
2021 38 38
2022 42 42
2023 132 132
2024 10 10

Device Problems MDRs with this Device Problem Events in those MDRs
Burst Container or Vessel 74 74
Adverse Event Without Identified Device or Use Problem 63 63
Material Rupture 59 59
Fluid/Blood Leak 45 45
Break 37 37
Leak/Splash 34 34
Difficult to Remove 25 25
Material Separation 21 21
Fracture 18 18
Device Contamination with Chemical or Other Material 17 17
Detachment of Device or Device Component 16 16
Material Deformation 14 14
Inflation Problem 13 13
Difficult to Advance 12 12
Material Split, Cut or Torn 11 11
Material Puncture/Hole 11 11
Appropriate Term/Code Not Available 9 9
Material Fragmentation 9 9
Torn Material 7 7
Use of Device Problem 7 7
Obstruction of Flow 6 6
Material Integrity Problem 6 6
Material Twisted/Bent 5 5
Device Operates Differently Than Expected 5 5
Nonstandard Device 5 5
Fitting Problem 5 5
Detachment Of Device Component 4 4
Defective Device 4 4
Stretched 4 4
Difficult to Insert 4 4
Deflation Problem 4 4
Device Dislodged or Dislocated 4 4
Connection Problem 4 4
Entrapment of Device 3 3
Crack 3 3
Difficult to Open or Remove Packaging Material 2 2
Kinked 2 2
Device Contaminated During Manufacture or Shipping 2 2
Hole In Material 2 2
Device Packaging Compromised 2 2
Device Handling Problem 2 2
Positioning Failure 2 2
Separation Failure 2 2
Complete Blockage 2 2
Unsealed Device Packaging 2 2
Component Missing 2 2
Deformation Due to Compressive Stress 2 2
Tear, Rip or Hole in Device Packaging 2 2
Product Quality Problem 2 2
Compatibility Problem 1 1
Migration 1 1
Contamination 1 1
Device Fell 1 1
Failure to Capture 1 1
Failure to Advance 1 1
Gas/Air Leak 1 1
Calcified 1 1
Inadequate Instructions for Healthcare Professional 1 1
No Flow 1 1
Retraction Problem 1 1
Unintended Ejection 1 1
Therapeutic or Diagnostic Output Failure 1 1
Difficult to Open or Close 1 1
Balloon rupture 1 1
Unraveled Material 1 1
Misassembled 1 1
Out-Of-Box Failure 1 1
Mechanical Jam 1 1
Component Incompatible 1 1
Pressure Problem 1 1
Decrease in Pressure 1 1
Failure to Infuse 1 1
Accessory Incompatible 1 1
Peeled/Delaminated 1 1
Device Damaged Prior to Use 1 1
Malposition of Device 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Mechanical Problem 1 1
Difficult To Position 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 146 146
No Consequences Or Impact To Patient 137 137
No Known Impact Or Consequence To Patient 85 85
No Code Available 58 58
Hemorrhage/Bleeding 19 19
Foreign Body In Patient 14 14
No Patient Involvement 12 12
Sepsis 12 12
Obstruction/Occlusion 10 10
No Information 10 10
Insufficient Information 10 10
Renal Failure 8 8
Tissue Damage 6 6
Urinary Tract Infection 6 6
Perforation 6 6
Septic Shock 5 5
Pain 4 4
Hematuria 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Device Embedded In Tissue or Plaque 4 4
Blood Loss 3 3
Pseudoaneurysm 3 3
Unspecified Infection 3 3
Abscess 3 3
Fistula 2 2
Hematoma 2 2
Pleural Effusion 2 2
Pneumonia 2 2
Pneumothorax 2 2
Post Operative Wound Infection 2 2
Respiratory Failure 2 2
Failure of Implant 2 2
Internal Organ Perforation 2 2
Transient Ischemic Attack 1 1
Urinary Retention 1 1
Perforation of Vessels 1 1
Anxiety 1 1
Liver Damage/Dysfunction 1 1
Hemothorax 1 1
Hypovolemic Shock 1 1
Pulmonary Embolism 1 1
Abdominal Pain 1 1
Cardiac Arrest 1 1
Deposits 1 1
Purulent Discharge 1 1
Embolism 1 1
Fever 1 1
Bowel Perforation 1 1
Fluid Discharge 1 1
Respiratory Insufficiency 1 1
Unspecified Kidney or Urinary Problem 1 1
Unspecified Tissue Injury 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation II Jul-09-2013
2 C.R. Bard, Inc. II Nov-04-2016
3 Cook Inc. II Dec-22-2021
4 Cook Inc. II Oct-14-2020
5 Cook Inc. II Feb-04-2020
6 Cook Inc. II Mar-24-2016
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