• 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
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
2017 63 63
2018 40 40
2019 82 82
2020 92 92
2021 97 3635
2022 60 60

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 253 2083
Break 59 913
Mechanical Problem 51 783
Difficult to Remove 17 17
Device Operates Differently Than Expected 10 10
Insufficient Information 7 7
Material Separation 7 7
Activation, Positioning or SeparationProblem 6 6
Detachment of Device or Device Component 5 5
Device Inoperable 5 5
Fracture 5 5
Detachment Of Device Component 4 4
Malposition of Device 3 3
Appropriate Term/Code Not Available 3 3
Mechanical Jam 2 124
Device Dislodged or Dislocated 2 2
Material Distortion 2 2
Material Integrity Problem 2 2
Use of Device Problem 2 2
Contamination 2 2
Crack 1 1
Entrapment of Device 1 1
Device Slipped 1 1
Improper or Incorrect Procedure or Method 1 1
Fitting Problem 1 1
Failure to Advance 1 1
Physical Resistance 1 1
Patient-Device Incompatibility 1 1
Deformation Due to Compressive Stress 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Material Protrusion/Extrusion 1 1
Material Deformation 1 1
Difficult to Advance 1 1
Patient Device Interaction Problem 1 1
Pressure Problem 1 1
Torn Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Iatrogenic Source 188 432
Device Embedded In Tissue or Plaque 134 1720
Cardiac Perforation 122 976
Pericardial Effusion 48 292
Atrial Perforation 35 35
Death 26 26
Low Blood Pressure/ Hypotension 25 25
No Known Impact Or Consequence To Patient 25 25
No Clinical Signs, Symptoms or Conditions 21 1119
Perforation of Vessels 15 15
Great Vessel Perforation 14 14
Injury 13 13
No Consequences Or Impact To Patient 12 12
No Code Available 11 11
Cardiac Tamponade 10 10
Unspecified Infection 7 7
Perforation 4 4
Foreign Body In Patient 4 4
No Information 3 3
Blood Loss 3 3
Pleural Effusion 3 3
Tissue Damage 3 3
Laceration(s) 3 3
Exsanguination 2 2
Calcium Deposits/Calcification 2 2
Hemorrhage/Bleeding 2 2
Excessive Tear Production 2 2
Complaint, Ill-Defined 2 2
Diminished Pulse Pressure 1 1
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Tricuspid Regurgitation 1 1
Scar Tissue 1 1
Scarring 1 1
Thrombus 1 1
Foreign Body Sensation in Eye 1 1
Adhesion(s) 1 1
Atrial Fibrillation 1 1
Bradycardia 1 1
Pain 1 1

-
-