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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
2018 46 46
2019 65 65
2020 65 65
2021 69 69
2022 105 105
2023 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Break 85 85
Detachment of Device or Device Component 68 68
Flaked 59 59
Adverse Event Without Identified Device or Use Problem 53 53
Material Integrity Problem 43 43
Device Damaged by Another Device 35 35
Material Fragmentation 28 28
Peeled/Delaminated 25 25
Unraveled Material 20 20
Material Protrusion/Extrusion 19 19
Material Deformation 18 18
Material Twisted/Bent 15 15
Improper Chemical Reaction 14 14
Difficult to Advance 11 11
Entrapment of Device 11 11
Use of Device Problem 7 7
Difficult to Remove 5 5
Material Separation 5 5
Tear, Rip or Hole in Device Packaging 5 5
Difficult to Insert 4 4
Product Quality Problem 3 3
Device Damaged Prior to Use 3 3
Component Missing 3 3
Deformation Due to Compressive Stress 3 3
Material Too Rigid or Stiff 3 3
Device Contamination with Chemical or Other Material 3 3
Appropriate Term/Code Not Available 3 3
Component Misassembled 2 2
Device-Device Incompatibility 2 2
Contamination /Decontamination Problem 2 2
Activation, Positioning or Separation Problem 2 2
Defective Device 2 2
Unsealed Device Packaging 2 2
Off-Label Use 2 2
Incorrect Measurement 2 2
Bent 2 2
Fracture 2 2
Material Frayed 1 1
Burst Container or Vessel 1 1
Detachment Of Device Component 1 1
Nonstandard Device 1 1
Material Invagination 1 1
Malposition of Device 1 1
Biocompatibility 1 1
Structural Problem 1 1
Failure to Advance 1 1
Inadequacy of Device Shape and/or Size 1 1
Problem with Sterilization 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Failure to Unfold or Unwrap 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Device Operates Differently Than Expected 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Physical Resistance/Sticking 1 1
Sharp Edges 1 1
Device Fell 1 1
Illegible Information 1 1
Positioning Problem 1 1
No Apparent Adverse Event 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 176 176
No Consequences Or Impact To Patient 97 97
No Known Impact Or Consequence To Patient 46 46
No Patient Involvement 19 19
Foreign Body In Patient 15 15
Device Embedded In Tissue or Plaque 13 13
Perforation 8 8
No Information 5 5
No Code Available 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Death 4 4
Hemorrhage/Bleeding 3 3
Inflammation 3 3
Pain 3 3
Abdominal Pain 1 1
Swelling 1 1
Tissue Damage 1 1
Injury 1 1
Disability 1 1
Hematuria 1 1
Blood Loss 1 1
Internal Organ Perforation 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Dyspnea 1 1
Edema 1 1
Extravasation 1 1
Dysuria 1 1
Insufficient Information 1 1

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