• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device stylet, catheter
Regulation Description Catheter stylet.
Product CodeDRB
Regulation Number 870.1380
Device Class 2


Premarket Reviews
ManufacturerDecision
BIOTRONIK GMBG & CO.
  SUBSTANTIALLY EQUIVALENT 1
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 1
GALT MEDICAL CORP.
  SUBSTANTIALLY EQUIVALENT 1
THERAGENICS 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 23 1243

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 157 645
Mechanical Problem 51 783
Break 34 34
Device Operates Differently Than Expected 20 20
Difficult to Remove 19 19
Insufficient Information 12 12
Material Separation 7 7
Fracture 6 6
Activation, Positioning or SeparationProblem 6 6
Detachment Of Device Component 6 6
Device Inoperable 6 6
Detachment of Device or Device Component 5 5
Appropriate Term/Code Not Available 5 5
Retraction Problem 4 4
Device Dislodged or Dislocated 3 3
Malposition of Device 3 3
Contamination 3 3
Material Integrity Problem 3 3
Material Deformation 2 2
Material Distortion 2 2
Entrapment of Device 2 2
Failure to Advance 2 2
Patient-Device Incompatibility 2 2
Mechanical Jam 2 2
Material Too Rigid or Stiff 2 2
Use of Device Problem 2 2
Calcified 2 2
Crack 1 1
Device Expiration Issue 1 1
Filling Problem 1 1
Material Fragmentation 1 1
Migration or Expulsion of Device 1 1
Material Perforation 1 1
Cut In Material 1 1
Failure to Align 1 1
Physical Resistance 1 1
Shelf Life Exceeded 1 1
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Device Handling Problem 1 1
Patient Device Interaction Problem 1 1
Deformation Due to Compressive Stress 1 1
Human Factors Issue 1 1
Material Protrusion/Extrusion 1 1
Backflow 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Difficult to Advance 1 1
Device Contamination with Chemical or Other Material 1 1
Impedance Problem 1 1
Difficult to Insert 1 1
Occlusion Within Device 1 1
Over-Sensing 1 1
Pacing Problem 1 1
Pocket Stimulation 1 1
Mechanics Altered 1 1
Pressure Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Iatrogenic Source 188 432
Device Embedded In Tissue or Plaque 82 936
Cardiac Perforation 65 309
Low Blood Pressure/ Hypotension 46 46
Atrial Perforation 35 35
Death 34 34
No Known Impact Or Consequence To Patient 32 32
Pericardial Effusion 24 24
Injury 23 23
Unspecified Infection 20 20
Perforation of Vessels 16 16
Cardiac Tamponade 16 16
No Consequences Or Impact To Patient 14 14
Perforation 12 12
No Code Available 11 11
Great Vessel Perforation 10 10
Tissue Damage 8 8
Foreign Body In Patient 8 8
Laceration(s) 7 7
Hemorrhage/Bleeding 4 4
Blood Loss 4 4
No Information 3 3
Calcium Deposits/Calcification 3 3
Excessive Tear Production 3 3
Exsanguination 2 2
Sepsis 2 2
Thrombus 2 2
Scarring 2 2
Complaint, Ill-Defined 2 2
Tricuspid Regurgitation 1 1
Ventricular Fibrillation 1 1
Foreign Body Sensation in Eye 1 1
Pleural Effusion 1 1
Scar Tissue 1 1
Adhesion(s) 1 1
Atrial Fibrillation 1 1
Bacterial Infection 1 1
Bradycardia 1 1
Bruise/Contusion 1 1
Cardiac Arrest 1 1
Low Pulmonary Arterial Wedge Pressure 1 1
Diminished Pulse Pressure 1 1
Occlusion 1 1
Hematoma 1 1
Endocarditis 1 1
Discharge 1 1
No Clinical Signs, Symptoms or Conditions 1 123
Vessel Or Plaque, Device Embedded In 1 1

-
-