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TPLC
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Device
catheter, nephrostomy
Product Code
LJE
Device Class
Unclassified
Premarket Reviews
Manufacturer
Decision
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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