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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cardiovascular procedure kit
Regulation Description Diagnostic intravascular catheter.
Definition This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product CodeOEZ
Regulation Number 870.1200
Device Class 2

MDR Year MDR Reports MDR Events
2016 44 44
2017 42 42
2018 58 58
2019 71 71
2020 65 65
2021 35 35

Device Problems MDRs with this Device Problem Events in those MDRs
Tear, Rip or Hole in Device Packaging 41 41
Fluid Leak 28 28
Disconnection 26 26
Air Leak 25 25
Problem with Sterilization 18 18
Leak/Splash 17 17
Material Fragmentation 17 17
Device Contamination with Chemical or Other Material 15 15
Break 13 13
Contamination /Decontamination Problem 11 11
Material Frayed 9 9
Unsealed Device Packaging 8 8
Connection Problem 8 8
Adverse Event Without Identified Device or Use Problem 8 8
Material Separation 7 7
Device Reprocessing Problem 7 7
Crack 7 7
Material Puncture/Hole 5 5
Material Rupture 4 4
Fracture 4 4
Component Missing 4 4
Improper Flow or Infusion 4 4
Device Contaminated During Manufacture or Shipping 4 4
Device Handling Problem 4 4
Insufficient Information 4 4
No Flow 3 3
Packaging Problem 3 3
Detachment of Device or Device Component 3 3
Contamination 3 3
Fire 3 3
Particulates 2 2
Misconnection 2 2
Uncoiled 2 2
Degraded 2 2
Hole In Material 2 2
Device Misassembled During Manufacturing /Shipping 2 2
Device Operational Issue 2 2
Device Dislodged or Dislocated 2 2
Defective Device 2 2
Air/Gas in Device 2 2
Incomplete or Inadequate Connection 2 2
Separation Problem 1 1
Appropriate Term/Code Not Available 1 1
Component Misassembled 1 1
Material Split, Cut or Torn 1 1
Device Fell 1 1
Facilities Issue 1 1
Therapeutic or Diagnostic Output Failure 1 1
No Apparent Adverse Event 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Infusion or Flow Problem 1 1
Inflation Problem 1 1
Loose or Intermittent Connection 1 1
Material Discolored 1 1
Material Disintegration 1 1
Use of Device Problem 1 1
Metal Shedding Debris 1 1
Improper or Incorrect Procedure or Method 1 1
Suction Problem 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Nonstandard Device 1 1
Increase in Pressure 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 88 88
Blood Loss 63 63
No Clinical Signs, Symptoms or Conditions 51 51
No Patient Involvement 40 40
No Consequences Or Impact To Patient 34 34
Not Applicable 30 30
Insufficient Information 9 9
Air Embolism 7 7
Death 7 7
No Information 5 5
Foreign Body In Patient 5 5
Post Operative Wound Infection 3 3
Hemolysis 3 3
Cardiac Arrest 2 2
Stroke/CVA 2 2
Patient Problem/Medical Problem 2 2
Sudden Cardiac Death 1 1
Device Embedded In Tissue or Plaque 1 1
Therapeutic Response, Decreased 1 1
Ventilator Dependent 1 1
Arrhythmia 1 1
Exposure to Body Fluids 1 1
Burn(s) 1 1
Hemorrhage/Bleeding 1 1
Hepatitis 1 1
Ischemia 1 1
Laceration(s) 1 1
Nerve Damage 1 1
ST Segment Elevation 1 1
Seizures 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AngioDynamics Inc. II Apr-07-2016
2 Avid Medical, Inc. I Jun-04-2021
3 Avid Medical, Inc. II Mar-19-2020
4 Medline Industries Inc II Jan-07-2021
5 ROi CPS LLC II Apr-08-2021
6 Terumo Cardiovascular Systems Corp II Jul-26-2018
7 Terumo Cardiovascular Systems Corp II Apr-06-2018
8 Terumo Cardiovascular Systems Corp II Aug-31-2016
9 Terumo Cardiovascular Systems Corporation II Feb-27-2019
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