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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 89 89

Device Problems MDRs with this Device Problem Events in those MDRs
Flaked 135 135
Detachment of Device or Device Component 114 114
Adverse Event Without Identified Device or Use Problem 101 101
Break 88 88
Material Fragmentation 46 46
Peeled/Delaminated 35 35
Material Integrity Problem 29 29
Material Protrusion/Extrusion 27 27
Unraveled Material 26 26
Device Damaged by Another Device 21 21
Difficult to Advance 20 20
Material Twisted/Bent 17 17
Improper Chemical Reaction 16 16
Material Deformation 16 16
Difficult to Insert 11 11
Entrapment of Device 11 11
Difficult to Remove 8 8
Use of Device Problem 8 8
Inadequacy of Device Shape and/or Size 6 6
Tear, Rip or Hole in Device Packaging 6 6
Material Too Rigid or Stiff 6 6
Material Separation 5 5
Device Contamination with Chemical or Other Material 5 5
Device-Device Incompatibility 5 5
Device Handling Problem 5 5
Missing Information 5 5
Sharp Edges 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
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
Defective Device 2 2
Malposition of Device 1 1
Biocompatibility 1 1
Structural Problem 1 1
Failure to Advance 1 1
Device Misassembled During Manufacturing /Shipping 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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 364 364
No Consequences Or Impact To Patient 75 75
No Known Impact Or Consequence To Patient 34 34
Foreign Body In Patient 21 21
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 20 20
No Patient Involvement 19 19
Perforation 14 14
Insufficient Information 14 14
Device Embedded In Tissue or Plaque 11 11
Hemorrhage/Bleeding 9 9
Fever 7 7
Laceration(s) 6 6
Sepsis 5 5
Pain 5 5
Unspecified Infection 4 4
No Code Available 4 4
Hematuria 3 3
Septic Shock 3 3
Exposure to Body Fluids 3 3
Urinary Tract Infection 2 2
Low Blood Pressure/ Hypotension 2 2
Swelling/ Edema 2 2
Extravasation 2 2
Chills 2 2
Anemia 2 2
Urinary Incontinence 2 2
Nausea 2 2
Death 2 2
Abdominal Pain 2 2
Thrombosis/Thrombus 1 1
Injury 1 1
Swelling 1 1
Discomfort 1 1
Multiple Organ Failure 1 1
Blood Loss 1 1
Edema 1 1
Abscess 1 1
Inflammation 1 1
Unspecified Tissue Injury 1 1
No Information 1 1
Tissue Damage 1 1
Disability 1 1
Internal Organ Perforation 1 1
Fistula 1 1
Lethargy 1 1

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