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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device cardiac catheterization kit
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 CodeOES
Regulation Number 870.1200
Device Class 2

MDR Year MDR Reports MDR Events
2017 2 2
2018 12 12
2019 13 13
2020 35 35
2021 21 21
2022 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 7 7
Contamination /Decontamination Problem 6 6
Unraveled Material 6 6
Failure to Advance 6 6
Material Frayed 6 6
Crack 5 5
Break 5 5
Material Separation 4 4
Tear, Rip or Hole in Device Packaging 4 4
Packaging Problem 4 4
Physical Resistance/Sticking 4 4
Material Integrity Problem 3 3
Activation, Positioning or SeparationProblem 3 3
Difficult to Insert 3 3
Leak/Splash 3 3
Particulates 3 3
Stretched 2 2
Detachment of Device or Device Component 2 2
Difficult to Advance 2 2
Material Deformation 2 2
Material Fragmentation 2 2
Deformation Due to Compressive Stress 2 2
Insufficient Information 2 2
Material Split, Cut or Torn 2 2
Air/Gas in Device 1 1
Material Twisted/Bent 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Pressure Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Defective Device 1 1
Dull, Blunt 1 1
Obstruction of Flow 1 1
Defective Component 1 1
Gas Leak 1 1
Device Contamination With Biological Material 1 1
Contamination of Device Ingredient or Reagent 1 1
Detachment Of Device Component 1 1
Degraded 1 1
Difficult or Delayed Positioning 1 1
Fluid Leak 1 1
Peeled/Delaminated 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Difficult to Remove 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 31 31
No Known Impact Or Consequence To Patient 16 16
No Consequences Or Impact To Patient 13 13
No Patient Involvement 6 6
No Information 6 6
Insufficient Information 5 5
No Code Available 1 1
Device Embedded In Tissue or Plaque 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Air Embolism 1 1
Death 1 1
Low Blood Pressure/ Hypotension 1 1
Obstruction/Occlusion 1 1
Needle Stick/Puncture 1 1
Underdose 1 1
Blood Loss 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II May-06-2022
3 Avid Medical, Inc. II Mar-19-2020
4 Centurion Medical Products Corporation II Oct-09-2019
5 Merit Medical Systems, Inc. II Oct-01-2019
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