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TPLC
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Device
stylet for catheter, gastro-urology
Product Code
EZB
Regulation Number
876.5130
Device Class
1
MDR Year
MDR Reports
MDR Events
2014
215
215
2015
53
53
2016
74
74
2017
58
58
2018
46
46
2019
65
65
2020
65
65
2021
69
69
2022
103
103
2023
179
179
2024
38
38
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment Of Device Component
247
247
Break
153
153
Flaked
136
136
Detachment of Device or Device Component
109
109
Adverse Event Without Identified Device or Use Problem
87
87
Device Damaged by Another Device
73
73
Material Integrity Problem
64
64
Material Fragmentation
44
44
Peeled/Delaminated
43
43
Unraveled Material
33
33
Material Deformation
33
33
Material Protrusion/Extrusion
29
29
Difficult to Advance
18
18
Material Twisted/Bent
17
17
Improper Chemical Reaction
16
16
Entrapment of Device
13
13
Difficult to Insert
12
12
Difficult to Remove
10
10
Device Damaged Prior to Use
9
9
Use of Device Problem
8
8
Tear, Rip or Hole in Device Packaging
8
8
Device Contamination with Chemical or Other Material
7
7
Material Too Rigid or Stiff
7
7
Material Separation
7
7
Inadequacy of Device Shape and/or Size
6
6
Bent
6
6
Device Handling Problem
5
5
Device-Device Incompatibility
4
4
Deformation Due to Compressive Stress
4
4
Fracture
4
4
Missing Information
4
4
Appropriate Term/Code Not Available
3
3
Sharp Edges
3
3
Accessory Incompatible
3
3
Material Frayed
3
3
Unsealed Device Packaging
3
3
Incorrect Measurement
3
3
Component Missing
3
3
Defective Device
3
3
Product Quality Problem
3
3
Device Contaminated During Manufacture or Shipping
3
3
Patient Device Interaction Problem
2
2
Component Misassembled
2
2
Positioning Problem
2
2
Device Operates Differently Than Expected
2
2
Device Packaging Compromised
2
2
Contamination /Decontamination Problem
2
2
Activation, Positioning or Separation Problem
2
2
Improper or Incorrect Procedure or Method
2
2
Off-Label Use
2
2
Problem with Sterilization
1
1
Shipping Damage or Problem
1
1
Fitting Problem
1
1
Out-Of-Box Failure
1
1
Metal Shedding Debris
1
1
Failure to Unfold or Unwrap
1
1
Mechanical Problem
1
1
Nonstandard Device
1
1
Material Invagination
1
1
Burst Container or Vessel
1
1
Coiled
1
1
Component Falling
1
1
Difficult or Delayed Positioning
1
1
Malposition of Device
1
1
Biocompatibility
1
1
Structural Problem
1
1
Failure to Advance
1
1
Split
1
1
Device Misassembled During Manufacturing /Shipping
1
1
Scratched Material
1
1
No Apparent Adverse Event
1
1
Physical Resistance/Sticking
1
1
Manufacturing, Packaging or Shipping Problem
1
1
Mechanical Jam
1
1
Device Fell
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Consequences Or Impact To Patient
402
402
No Clinical Signs, Symptoms or Conditions
335
335
No Known Impact Or Consequence To Patient
93
93
No Patient Involvement
34
34
Foreign Body In Patient
29
29
Device Embedded In Tissue or Plaque
23
23
Perforation
22
22
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
20
20
No Information
15
15
No Code Available
7
7
Hemorrhage/Bleeding
7
7
Death
6
6
Pain
6
6
Inflammation
5
5
Unspecified Infection
4
4
Insufficient Information
4
4
Septic Shock
3
3
Internal Organ Perforation
3
3
Hematuria
2
2
Chills
2
2
Nausea
2
2
Abdominal Pain
2
2
Exposure to Body Fluids
2
2
Low Blood Pressure/ Hypotension
2
2
Extravasation
2
2
Fever
2
2
Swelling/ Edema
2
2
Fistula
1
1
Hypoxia
1
1
Cardiac Arrest
1
1
Dyspnea
1
1
Edema
1
1
Laceration(s)
1
1
Swelling
1
1
Tissue Damage
1
1
Urinary Tract Infection
1
1
Test Result
1
1
Thrombosis/Thrombus
1
1
Unspecified Tissue Injury
1
1
Lethargy
1
1
Blood Loss
1
1
Dysuria
1
1
Injury
1
1
Disability
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Boston Scientific
II
Apr-01-2020
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