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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
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 CodeOES
Regulation Number 870.1200
Device Class 2

MDR Year MDR Reports MDR Events
2016 4 4
2017 2 2
2018 12 12
2019 13 13
2020 35 35
2021 16 16

Device Problems MDRs with this Device Problem Events in those MDRs
Device Contamination with Chemical or Other Material 7 7
Failure to Advance 6 6
Contamination /Decontamination Problem 6 6
Unraveled Material 6 6
Crack 6 6
Break 5 5
Material Separation 4 4
Detachment of Device or Device Component 4 4
Material Frayed 4 4
Physical Resistance/Sticking 4 4
Difficult to Insert 3 3
Particulates 3 3
Activation, Positioning or SeparationProblem 3 3
Deformation Due to Compressive Stress 2 2
Insufficient Information 2 2
Material Split, Cut or Torn 2 2
Material Fragmentation 2 2
Stretched 2 2
Leak/Splash 2 2
Material Deformation 2 2
Difficult to Advance 2 2
Air/Gas in Device 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Pressure Problem 1 1
Contamination of Device Ingredient or Reagent 1 1
Device Contamination With Biological Material 1 1
Peeled/Delaminated 1 1
Product Quality Problem 1 1
Defective Component 1 1
Dull, Blunt 1 1
Detachment Of Device Component 1 1
Difficult or Delayed Positioning 1 1
Obstruction of Flow 1 1
Defective Device 1 1
Gas Leak 1 1
Material Twisted/Bent 1 1
Therapeutic or Diagnostic Output Failure 1 1
Fluid Leak 1 1
Material Puncture/Hole 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 21 21
No Known Impact Or Consequence To Patient 18 18
No Consequences Or Impact To Patient 14 14
No Patient Involvement 6 6
No Information 6 6
Insufficient Information 5 5
Underdose 1 1
Air Embolism 1 1
Low Blood Pressure/ Hypotension 1 1
No Code Available 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Device Embedded In Tissue or Plaque 1 1
Arrhythmia 1 1
Atrial Fibrillation 1 1
Death 1 1
Obstruction/Occlusion 1 1
Needle Stick/Puncture 1 1
Blood Loss 1 1

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