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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 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 337 2167
Break 63 917
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
Mechanical Jam 2 124
Device Contaminated During Manufacture or Shipping 1 1
Material Deformation 1 1
Material Integrity Problem 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 187 1773
Cardiac Perforation 168 1022
Iatrogenic Source 165 409
Pericardial Effusion 93 337
No Clinical Signs, Symptoms or Conditions 36 1134
Atrial Perforation 32 32
Perforation of Vessels 20 20
Great Vessel Perforation 19 19
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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