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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stylet for catheter, gastro-urology
Product CodeEZB
Regulation Number 876.5130
Device Class 1

MDR Year MDR Reports MDR Events
2019 65 65
2020 65 65
2021 69 69
2022 103 103
2023 179 179
2024 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Flaked 129 129
Detachment of Device or Device Component 101 101
Break 85 85
Adverse Event Without Identified Device or Use Problem 73 73
Material Fragmentation 41 41
Peeled/Delaminated 29 29
Material Integrity Problem 29 29
Material Protrusion/Extrusion 26 26
Unraveled Material 26 26
Device Damaged by Another Device 21 21
Difficult to Advance 17 17
Improper Chemical Reaction 16 16
Material Deformation 16 16
Material Twisted/Bent 15 15
Difficult to Insert 11 11
Entrapment of Device 11 11
Use of Device Problem 8 8
Difficult to Remove 7 7
Material Too Rigid or Stiff 6 6
Inadequacy of Device Shape and/or Size 6 6
Tear, Rip or Hole in Device Packaging 6 6
Material Separation 5 5
Device Handling Problem 5 5
Device Contamination with Chemical or Other Material 4 4
Device-Device Incompatibility 4 4
Missing Information 4 4
Deformation Due to Compressive Stress 4 4
Device Damaged Prior to Use 3 3
Component Missing 3 3
Incorrect Measurement 3 3
Accessory Incompatible 3 3
Appropriate Term/Code Not Available 3 3
Sharp Edges 3 3
Unsealed Device Packaging 3 3
Device Contaminated During Manufacture or Shipping 2 2
Patient Device Interaction Problem 2 2
Component Misassembled 2 2
Product Quality Problem 2 2
Contamination /Decontamination Problem 2 2
Activation, Positioning or Separation Problem 2 2
Device Misassembled During Manufacturing /Shipping 1 1
Structural Problem 1 1
Failure to Advance 1 1
Defective Device 1 1
Malposition of Device 1 1
Biocompatibility 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Problem with Sterilization 1 1
Failure to Unfold or Unwrap 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Shipping Damage or Problem 1 1
Burst Container or Vessel 1 1
Material Invagination 1 1
Fracture 1 1
Physical Resistance/Sticking 1 1
Scratched Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Device Fell 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 327 327
No Consequences Or Impact To Patient 75 75
No Known Impact Or Consequence To Patient 34 34
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
Foreign Body In Patient 20 20
No Patient Involvement 19 19
Perforation 13 13
Device Embedded In Tissue or Plaque 11 11
Hemorrhage/Bleeding 5 5
No Code Available 4 4
Insufficient Information 4 4
Pain 4 4
Septic Shock 3 3
Unspecified Infection 3 3
Nausea 2 2
Low Blood Pressure/ Hypotension 2 2
Extravasation 2 2
Fever 2 2
Abdominal Pain 2 2
Exposure to Body Fluids 2 2
Death 2 2
Chills 2 2
Swelling/ Edema 2 2
Thrombosis/Thrombus 1 1
Unspecified Tissue Injury 1 1
No Information 1 1
Injury 1 1
Disability 1 1
Lethargy 1 1
Blood Loss 1 1
Edema 1 1
Fistula 1 1
Internal Organ Perforation 1 1
Inflammation 1 1
Laceration(s) 1 1
Swelling 1 1
Tissue Damage 1 1
Urinary Tract Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific II Apr-01-2020
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