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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stylet, catheter
Product CodeDRB
Regulation Number 870.1380
Device Class 2


Premarket Reviews
ManufacturerDecision
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 1
BIOTRONIK, INC
  SUBSTANTIALLY EQUIVALENT 1
COOK INCORPORATED
  SUBSTANTIALLY EQUIVALENT 1
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRANETICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ST. JUDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2014 67 67
2015 66 66
2016 55 55
2017 63 63
2018 40 40
2019 82 82
2020 92 92
2021 97 3635
2022 94 94
2023 82 82
2024 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 394 2224
Break 94 948
Mechanical Problem 52 784
Insufficient Information 38 38
Difficult to Remove 33 33
Device Operates Differently Than Expected 28 28
Material Separation 17 17
Failure to Advance 12 12
Retraction Problem 10 10
Device Inoperable 10 10
Detachment Of Device Component 9 9
Difficult to Advance 8 8
Appropriate Term/Code Not Available 7 7
Activation, Positioning or Separation Problem 6 6
Detachment of Device or Device Component 6 6
Fracture 6 6
Device Expiration Issue 5 5
Sticking 5 5
Positioning Problem 5 5
Human-Device Interface Problem 4 4
Device Dislodged or Dislocated 4 4
Occlusion Within Device 4 4
Entrapment of Device 4 4
Difficult to Insert 3 3
Contamination 3 3
Shelf Life Exceeded 3 3
Use of Device Problem 3 3
Physical Resistance 3 3
Malposition of Device 3 3
Device Markings/Labelling Problem 3 3
Material Integrity Problem 3 3
Mechanical Jam 3 125
Pressure Problem 2 2
Physical Resistance/Sticking 2 2
Material Deformation 2 2
Material Distortion 2 2
Patient-Device Incompatibility 2 2
Improper or Incorrect Procedure or Method 2 2
Fitting Problem 2 2
Material Perforation 2 2
Cut In Material 2 2
Product Quality Problem 2 2
Device Slipped 2 2
Material Too Rigid or Stiff 2 2
Calcified 2 2
High impedance 2 2
Material Fragmentation 1 1
Material Frayed 1 1
Loose or Intermittent Connection 1 1
Migration or Expulsion of Device 1 1
Accessory Incompatible 1 1
Backflow 1 1
Crack 1 1
Filling Problem 1 1
Inadequacy of Device Shape and/or Size 1 1
Over-Sensing 1 1
Pacing Problem 1 1
Pocket Stimulation 1 1
Decrease in Pressure 1 1
Unexpected Therapeutic Results 1 1
Failure to Align 1 1
Deformation Due to Compressive Stress 1 1
Device Displays Incorrect Message 1 1
Device Contamination with Chemical or Other Material 1 1
Human Factors Issue 1 1
Material Protrusion/Extrusion 1 1
Impedance Problem 1 1
Device Contaminated During Manufacture or Shipping 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Scratched Material 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Mechanics Altered 1 1
Packaging Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 213 1799
Cardiac Perforation 192 1046
Iatrogenic Source 188 432
Pericardial Effusion 134 378
Low Blood Pressure/ Hypotension 113 113
No Known Impact Or Consequence To Patient 49 49
Death 42 42
Unspecified Infection 40 40
Atrial Perforation 36 36
No Clinical Signs, Symptoms or Conditions 36 1134
Injury 33 33
Perforation of Vessels 28 28
Cardiac Tamponade 27 27
Great Vessel Perforation 22 22
Perforation 21 21
Laceration(s) 20 20
No Consequences Or Impact To Patient 19 19
Foreign Body In Patient 17 17
Tissue Damage 13 13
No Code Available 12 12
Hemorrhage/Bleeding 10 10
Calcium Deposits/Calcification 9 9
Scarring 4 4
Pleural Effusion 4 4
No Information 4 4
Blood Loss 4 4
Excessive Tear Production 4 4
Complaint, Ill-Defined 3 3
Bacterial Infection 3 3
Cardiac Arrest 2 2
Hematoma 2 2
Endocarditis 2 2
Exsanguination 2 2
Sepsis 2 2
Thrombus 2 2
Fibrosis 2 2
Diminished Pulse Pressure 1 1
Low Oxygen Saturation 1 1
Low Pulmonary Arterial Wedge Pressure 1 1
Vascular System (Circulation), Impaired 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Tricuspid Regurgitation 1 1
Ventricular Fibrillation 1 1
Discharge 1 1
Staphylococcus Aureus 1 1
Scar Tissue 1 1
Occlusion 1 1
Internal Organ Perforation 1 1
Pain 1 1
Fistula 1 1
Foreign Body Sensation in Eye 1 1
Dry Eye(s) 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Vessel Or Plaque, Device Embedded In 1 1
Pulmonary Embolism 1 1
Adhesion(s) 1 1
Atrial Fibrillation 1 1

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