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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

MDR Year MDR Reports MDR Events
2016 55 55
2017 63 63
2018 40 40
2019 82 82
2020 92 92
2021 97 3635
2022 85 85

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 279 2109
Break 71 925
Mechanical Problem 51 783
Device Operates Differently Than Expected 20 20
Difficult to Remove 19 19
Insufficient Information 12 12
Material Separation 7 7
Detachment Of Device Component 6 6
Fracture 6 6
Activation, Positioning or Separation Problem 6 6
Detachment of Device or Device Component 6 6
Device Inoperable 6 6
Appropriate Term/Code Not Available 5 5
Retraction Problem 4 4
Contamination 3 3
Malposition of Device 3 3
Device Dislodged or Dislocated 3 3
Mechanical Jam 3 125
Material Integrity Problem 3 3
Material Deformation 2 2
Material Distortion 2 2
Patient-Device Incompatibility 2 2
Failure to Advance 2 2
Use of Device Problem 2 2
Calcified 2 2
Entrapment of Device 2 2
Material Too Rigid or Stiff 2 2
Shelf Life Exceeded 1 1
Device Slipped 1 1
Migration or Expulsion of Device 1 1
Occlusion Within Device 1 1
Over-Sensing 1 1
Pacing Problem 1 1
Pocket Stimulation 1 1
Device Expiration Issue 1 1
Filling Problem 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Crack 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Material Perforation 1 1
Cut In Material 1 1
Failure to Align 1 1
Physical Resistance 1 1
Deformation Due to Compressive Stress 1 1
Device Contamination with Chemical or Other Material 1 1
Human Factors Issue 1 1
Impedance Problem 1 1
Difficult to Advance 1 1
Material Protrusion/Extrusion 1 1
Packaging Problem 1 1
Pressure Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Mechanics Altered 1 1
Backflow 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Iatrogenic Source 188 432
Device Embedded In Tissue or Plaque 148 1734
Cardiac Perforation 137 991
Pericardial Effusion 63 307
Low Blood Pressure/ Hypotension 46 46
Atrial Perforation 35 35
Death 34 34
No Known Impact Or Consequence To Patient 32 32
Injury 23 23
No Clinical Signs, Symptoms or Conditions 21 1119
Unspecified Infection 20 20
Perforation of Vessels 19 19
Great Vessel Perforation 17 17
Cardiac Tamponade 17 17
No Consequences Or Impact To Patient 14 14
Perforation 12 12
No Code Available 11 11
Foreign Body In Patient 8 8
Laceration(s) 8 8
Tissue Damage 8 8
Blood Loss 4 4
Pleural Effusion 4 4
Hemorrhage/Bleeding 4 4
No Information 3 3
Calcium Deposits/Calcification 3 3
Excessive Tear Production 3 3
Complaint, Ill-Defined 2 2
Scarring 2 2
Sepsis 2 2
Thrombus 2 2
Exsanguination 2 2
Foreign Body Sensation in Eye 1 1
Hematoma 1 1
Scar Tissue 1 1
Occlusion 1 1
Pain 1 1
Cardiac Arrest 1 1
Endocarditis 1 1
Vessel Or Plaque, Device Embedded In 1 1
Pulmonary Embolism 1 1
Adhesion(s) 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Tricuspid Regurgitation 1 1
Ventricular Fibrillation 1 1
Discharge 1 1
Low Pulmonary Arterial Wedge Pressure 1 1
Diminished Pulse Pressure 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1

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