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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device stylet, catheter
Regulation Description Catheter stylet.
Product CodeDRB
Regulation Number 870.1380
Device Class 2


Premarket Reviews
ManufacturerDecision
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
  SUBSTANTIALLY EQUIVALENT 1
  1.  K220280  Arrow Stiffening Stylet

MDR Year MDR Reports MDR Events
2020 92 92
2021 97 3635
2022 94 94
2023 82 82
2024 116 116
2025 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 367 2197
Break 75 929
Mechanical Problem 27 759
Material Separation 12 12
Activation, Positioning or Separation Problem 2 2
Product Quality Problem 2 2
Mechanical Jam 2 124
Physical Resistance/Sticking 2 2
Device Damaged by Another Device 2 2
Delivered as Unsterile Product 1 1
Material Integrity Problem 1 1
Crack 1 1
Device Contaminated During Manufacture or Shipping 1 1
Deformation Due to Compressive Stress 1 1
Tear, Rip or Hole in Device Packaging 1 1
Device Slipped 1 1
Use of Device Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 202 1788
Cardiac Perforation 182 1036
Pericardial Effusion 111 355
Iatrogenic Source 93 337
No Clinical Signs, Symptoms or Conditions 40 1138
Perforation of Vessels 27 27
Atrial Perforation 22 22
Great Vessel Perforation 21 21
No Known Impact Or Consequence To Patient 12 12
Death 12 12
Cardiac Tamponade 11 11
Low Blood Pressure/ Hypotension 9 9
Pleural Effusion 3 3
Laceration(s) 2 2
No Consequences Or Impact To Patient 2 2
Foreign Body In Patient 2 2
Pulmonary Embolism 2 2
Hemorrhage/Bleeding 2 2
Obstruction/Occlusion 1 1
Internal Organ Perforation 1 1
Pain 1 1
Perforation 1 1
Thrombus 1 1
Pericarditis 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Atrial Fibrillation 1 1
Bradycardia 1 1

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