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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
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 82 82
2020 92 92
2021 97 3635
2022 94 94
2023 82 82
2024 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 352 2182
Break 64 918
Mechanical Problem 48 780
Material Separation 14 14
Activation, Positioning or Separation Problem 6 6
Detachment of Device or Device Component 4 4
Use of Device Problem 3 3
Product Quality Problem 2 2
Difficult to Remove 2 2
Physical Resistance/Sticking 2 2
Material Integrity Problem 2 2
Mechanical Jam 2 124
Device Damaged by Another Device 1 1
Device Contaminated During Manufacture or Shipping 1 1
Material Deformation 1 1
Crack 1 1
Deformation Due to Compressive Stress 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 197 1783
Cardiac Perforation 175 1029
Iatrogenic Source 165 409
Pericardial Effusion 97 341
No Clinical Signs, Symptoms or Conditions 37 1135
Atrial Perforation 32 32
Perforation of Vessels 20 20
Great Vessel Perforation 20 20
Death 16 16
No Known Impact Or Consequence To Patient 13 13
Cardiac Tamponade 11 11
No Consequences Or Impact To Patient 8 8
Low Blood Pressure/ Hypotension 6 6
Pleural Effusion 3 3
No Code Available 3 3
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Thrombus 1 1
Tricuspid Regurgitation 1 1
Laceration(s) 1 1
Internal Organ Perforation 1 1
Pain 1 1
Perforation 1 1
Exsanguination 1 1
Hemorrhage/Bleeding 1 1
Pulmonary Embolism 1 1
Atrial Fibrillation 1 1
Bradycardia 1 1

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