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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
Regulation Description Urological catheter and accessories.
Product CodeEZB
Regulation Number 876.5130
Device Class 1

MDR Year MDR Reports MDR Events
2016 74 74
2017 58 58
2018 46 46
2019 65 65
2020 65 65
2021 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Break 98 98
Device Damaged by Another Device 66 66
Material Integrity Problem 60 60
Guidewire 44 44
Tip 33 33
Detachment of Device or Device Component 31 31
Material Deformation 29 29
Detachment Of Device Component 27 27
Adverse Event Without Identified Device or Use Problem 24 24
Peeled/Delaminated 21 21
Wire 16 16
Flaked 14 14
Unraveled Material 14 14
Material Fragmentation 11 11
Difficult to Advance 8 8
Entrapment of Device 7 7
Bent 6 6
Material Protrusion/Extrusion 6 6
Material Twisted/Bent 6 6
Core 5 5
Difficult to Remove 5 5
Material Too Rigid or Stiff 4 4
Device Contamination with Chemical or Other Material 4 4
Device Damaged Prior to Use 4 4
Tear, Rip or Hole in Device Packaging 4 4
Product Quality Problem 3 3
Material Separation 3 3
Appropriate Term/Code Not Available 3 3
Device Packaging Compromised 2 2
Device Operates Differently Than Expected 2 2
Defective Device 2 2
Activation, Positioning or SeparationProblem 2 2
Seal 2 2
Fracture 2 2
Off-Label Use 2 2
Use of Device Problem 2 2
Component Missing 2 2
Improper or Incorrect Procedure or Method 2 2
Contamination /Decontamination Problem 2 2
Positioning Problem 2 2
Device Fell 1 1
Device-Device Incompatibility 1 1
Device Contaminated During Manufacture or Shipping 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Fitting Problem 1 1
Malposition of Device 1 1
Material Frayed 1 1
Difficult to Insert 1 1
Out-Of-Box Failure 1 1
Structural Problem 1 1
Split 1 1
Metal Shedding Debris 1 1
Problem with Sterilization 1 1
Device Component Or Accessory 1 1
No Apparent Adverse Event 1 1
Component Falling 1 1
Difficult or Delayed Positioning 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 169 169
No Known Impact Or Consequence To Patient 83 83
No Patient Involvement 20 20
Device Embedded In Tissue or Plaque 20 20
No Information 15 15
Foreign Body In Patient 13 13
No Code Available 6 6
Death 5 5
Perforation 5 5
Hemorrhage/Bleeding 3 3
Pain 3 3
Inflammation 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Hematuria 1 1
Dysuria 1 1
Dyspnea 1 1
Swelling 1 1
Tissue Damage 1 1
Injury 1 1
Disability 1 1
Blood Loss 1 1
Hypoxia 1 1
Unspecified Infection 1 1
Internal Organ Perforation 1 1
Edema 1 1
Test Result 1 1
Cardiac Arrest 1 1

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