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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 11 11

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

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 35 35
No Known Impact Or Consequence To Patient 16 16
No Consequences Or Impact To Patient 13 13
Insufficient Information 7 7
No Information 6 6
No Patient Involvement 6 6
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
No Code Available 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II Sep-08-2022
3 American Contract Systems, Inc. II May-06-2022
4 Avid Medical, Inc. II Mar-19-2020
5 Centurion Medical Products Corporation II Oct-09-2019
6 Merit Medical Systems, Inc. II Oct-01-2019
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