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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 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 435 2265
Break 104 958
Mechanical Problem 53 785
Insufficient Information 38 38
Difficult to Remove 33 33
Device Operates Differently Than Expected 28 28
Material Separation 18 18
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
Fracture 6 6
Activation, Positioning or Separation Problem 6 6
Detachment of Device or Device Component 6 6
Device Expiration Issue 5 5
Positioning Problem 5 5
Sticking 5 5
Device Dislodged or Dislocated 4 4
Material Integrity Problem 4 4
Human-Device Interface Problem 4 4
Occlusion Within Device 4 4
Entrapment of Device 4 4
Use of Device Problem 3 3
Malposition of Device 3 3
Device Markings/Labelling Problem 3 3
Mechanical Jam 3 125
Difficult to Insert 3 3
Shelf Life Exceeded 3 3
Contamination 3 3
Physical Resistance 3 3
Material Too Rigid or Stiff 2 2
Calcified 2 2
Material Distortion 2 2
Patient-Device Incompatibility 2 2
Physical Resistance/Sticking 2 2
Product Quality Problem 2 2
Improper or Incorrect Procedure or Method 2 2
High impedance 2 2
Pressure Problem 2 2
Fitting Problem 2 2
Device Slipped 2 2
Cut In Material 2 2
Material Perforation 2 2
Material Deformation 2 2
Deformation Due to Compressive Stress 1 1
Pocket Stimulation 1 1
Unexpected Therapeutic Results 1 1
Over-Sensing 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Device Embedded In Tissue or Plaque 239 1825
Cardiac Perforation 210 1064
Iatrogenic Source 188 432
Pericardial Effusion 147 391
Low Blood Pressure/ Hypotension 115 115
No Known Impact Or Consequence To Patient 49 49
Death 42 42
Unspecified Infection 40 40
No Clinical Signs, Symptoms or Conditions 37 1135
Atrial Perforation 36 36
Perforation of Vessels 35 35
Injury 33 33
Cardiac Tamponade 28 28
Great Vessel Perforation 25 25
Perforation 21 21
Laceration(s) 21 21
No Consequences Or Impact To Patient 19 19
Foreign Body In Patient 18 18
Tissue Damage 13 13
No Code Available 12 12
Hemorrhage/Bleeding 11 11
Calcium Deposits/Calcification 9 9
Blood Loss 4 4
Scarring 4 4
Pleural Effusion 4 4
No Information 4 4
Excessive Tear Production 4 4
Bacterial Infection 3 3
Complaint, Ill-Defined 3 3
Cardiac Arrest 2 2
Hematoma 2 2
Exsanguination 2 2
Endocarditis 2 2
Sepsis 2 2
Fibrosis 2 2
Thrombus 2 2
Pulmonary Embolism 2 2
Obstruction/Occlusion 1 1
Atrial Fibrillation 1 1
Staphylococcus Aureus 1 1
Diminished Pulse Pressure 1 1
Dry Eye(s) 1 1
Ventricular Fibrillation 1 1
Adhesion(s) 1 1
Pain 1 1
Scar Tissue 1 1
Bradycardia 1 1
Vascular System (Circulation), Impaired 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Tricuspid Regurgitation 1 1

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