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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
2020 35 35
2021 21 21
2022 13 13
2023 18 18
2024 113 113
2025 33 33

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 37 37
Material Integrity Problem 26 26
Crack 23 23
Appropriate Term/Code Not Available 23 23
Break 21 21
Leak/Splash 9 9
Material Fragmentation 8 8
Contamination /Decontamination Problem 7 7
Unraveled Material 7 7
Failure to Advance 6 6
Material Frayed 6 6
Physical Resistance/Sticking 6 6
Fluid/Blood Leak 5 5
Material Deformation 5 5
Tear, Rip or Hole in Device Packaging 5 5
Contamination 4 4
Material Puncture/Hole 4 4
Material Separation 4 4
Obstruction of Flow 4 4
Packaging Problem 4 4
Difficult to Insert 3 3
Component Missing 3 3
Insufficient Information 3 3
Material Split, Cut or Torn 3 3
Activation, Positioning or Separation Problem 3 3
Defective Component 2 2
Stretched 2 2
No Apparent Adverse Event 2 2
Product Quality Problem 2 2
Retraction Problem 2 2
Difficult to Advance 2 2
Device Markings/Labelling Problem 2 2
Detachment of Device or Device Component 2 2
Deformation Due to Compressive Stress 2 2
Air/Gas in Device 2 2
Pressure Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Mechanical Jam 1 1
Material Twisted/Bent 1 1
Patient Device Interaction Problem 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Restricted Flow rate 1 1
Difficult or Delayed Positioning 1 1
Degraded 1 1
Burst Container or Vessel 1 1
Difficult to Remove 1 1
Peeled/Delaminated 1 1
Particulates 1 1
Melted 1 1
Incomplete or Missing Packaging 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 156 156
Insufficient Information 29 29
No Consequences Or Impact To Patient 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
No Known Impact Or Consequence To Patient 7 7
Foreign Body In Patient 3 3
Obstruction/Occlusion 3 3
Hemorrhage/Bleeding 3 3
Low Blood Pressure/ Hypotension 3 3
Abrasion 2 2
Exposure to Body Fluids 2 2
Patient Problem/Medical Problem 1 1
Unspecified Kidney or Urinary Problem 1 1
Needle Stick/Puncture 1 1
Air Embolism 1 1
Death 1 1

Recalls
Manufacturer Recall Class Date Posted
1 AVID Medical, Inc. II Nov-14-2024
2 American Contract Systems II May-29-2020
3 American Contract Systems, Inc. II Mar-21-2025
4 American Contract Systems, Inc. II Sep-24-2024
5 American Contract Systems, Inc. II Jan-26-2024
6 American Contract Systems, Inc. II Oct-26-2023
7 American Contract Systems, Inc. II Sep-08-2022
8 American Contract Systems, Inc. II May-06-2022
9 Avid Medical, Inc. II Mar-19-2020
10 Cardinal Health 200, LLC II Jul-10-2024
11 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
12 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
13 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
14 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
19 MEDLINE INDUSTRIES, LP - Northfield I Aug-08-2024
20 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
21 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
22 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
23 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
24 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
25 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
26 ROi CPS LLC II Apr-25-2023
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