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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device catheter, continuous flush
Regulation Description Continuous flush catheter.
Product CodeKRA
Regulation Number 870.1210
Device Class 2


Premarket Reviews
ManufacturerDecision
ABLATIVE SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
ANGIODYNAMICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
BOSTON SCIENTIFIC
  SUBSTANTIALLY EQUIVALENT 1
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 3
BOSTON SCIENTIFIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
BTG INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 5
COOK, INC.
  SUBSTANTIALLY EQUIVALENT 5
EDWARDS LIFESCIENCES
  SUBSTANTIALLY EQUIVALENT 4
EDWARDS LIFESCIENCES LLC
  SUBSTANTIALLY EQUIVALENT 2
EDWARDS LIFESCIENCES, LLC
  SUBSTANTIALLY EQUIVALENT 2
MERCATOR MEDSYSTEMS,
  SUBSTANTIALLY EQUIVALENT 2
MERCATOR MEDSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
MERIT MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 3
REX MEDICAL, L.P.
  SUBSTANTIALLY EQUIVALENT 1
VASCULAR INSIGHTS LLC
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Break 404
Catheter 372
Adverse Event Without Identified Device or Use Problem 176
Physical Resistance 120
Material Separation 115
Fracture 107
Aspiration Issue 82
Difficult to Remove 75
Physical Resistance / Sticking 74
Device Displays Incorrect Message 71
Burst Container or Vessel 67
Device Dislodged or Dislocated 63
Leak / Splash 54
Detachment Of Device Component 48
Obstruction of Flow 44
Detachment of Device or device Component 43
Device Damaged by Another Device 43
Entrapment of Device 42
Device Damaged Prior to Use 41
Shaft 40
Material Deformation 34
Balloon 33
Material Integrity Problem 32
Tip 32
Kinked 31
Fitting Problem 29
Material Rupture 22
Difficult to Advance 22
Fluid Leak 20
Material Puncture / Hole 18
Peeled / Delaminated 18
Material Perforation 17
Hole In Material 16
Inflation Problem 16
Guidewire 15
Occlusion Within Device 15
Stretched 14
Device Operates Differently Than Expected 13
Deformation Due to Compressive Stress 12
Device Handling Problem 12
Material Fragmentation 12
Device Inoperable 12
Device Contamination with Chemical or Other Material 11
Appropriate Term/Code Not Available 10
Delamination 10
Failure to Advance 9
Audible Prompt / Feedback 8
Difficult to Open or Remove Packaging Material 8
Difficult to Insert 8
Flaked 7
Hub 7
Torn Material 7
Deflation Problem 7
Crack 6
Electrical Shorting 6
Display or Visual Feedback Problem 5
Device Or Device Fragments Location Unknown 5
Positioning Problem 5
Mechanical Problem 5
Partial Blockage 4
Tear, Rip or Hole in Device Packaging 4
Bent 4
Contamination / decontamination Problem 4
Device Packaging Compromised 4
Device Difficult to Setup or Prepare 3
Material Split, Cut or Torn 3
Disconnection 3
Material Frayed 3
Suction Problem 3
Use of Device Problem 3
Radiation Underexposure 3
Split 3
Material Twisted / Bent 3
Packaging Problem 3
Insufficient Information 3
Failure to Prime 3
No Flow 3
Improper Flow or Infusion 2
Device Stops Intermittently 2
Port 2
Incorrect Measurement 2
Incorrect, Inadequate or Imprecise Result or Readings 2
Unraveled Material 2
Cut In Material 2
Complete Blockage 2
Wire 2
Coil 2
Device Issue 2
Tip breakage 2
Migration or Expulsion of Device 2
Device Markings / Labelling Problem 2
Separation Problem 2
No Apparent Adverse Event 2
Positioning Failure 2
Restricted Flow rate 2
Component Missing 2
Difficult To Position 2
Air Leak 1
Sharp Edges 1
Connection Problem 1
Total Device Problems 2752

Recalls
Manufacturer Recall Class Date Posted
1 Angiodynamics, Inc. II Aug-18-2014
2 Cook Inc. II Mar-02-2017
3 Cook Inc. II Nov-06-2015
4 Covidien I Feb-03-2015
5 EKOS Corporation II Sep-21-2016
6 EKOS Corporation II Feb-24-2016
7 EKOS Corporation II Jul-20-2015
8 Medtronic Inc. Cardiac Rhythm Disease Management II Apr-02-2015
9 Merit Medical Systems, Inc. II Oct-31-2014
10 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
11 Sequent Medical Inc II Oct-27-2016
12 Vascular Insights, LLC II Mar-21-2018

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