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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 101 101

Device Problems MDRs with this Device Problem Events in those MDRs
Connection Problem 53 53
Crack 31 31
Material Integrity Problem 28 28
Break 26 26
Appropriate Term/Code Not Available 24 24
Leak/Splash 10 10
Contamination /Decontamination Problem 10 10
Loose or Intermittent Connection 9 9
Unraveled Material 8 8
Material Fragmentation 8 8
Air/Gas in Device 8 8
Obstruction of Flow 7 7
Material Frayed 6 6
Fluid/Blood Leak 6 6
Failure to Advance 6 6
Material Deformation 6 6
Physical Resistance/Sticking 6 6
Tear, Rip or Hole in Device Packaging 5 5
Insufficient Information 5 5
Material Split, Cut or Torn 5 5
Material Puncture/Hole 5 5
Fitting Problem 4 4
Activation, Positioning or Separation Problem 4 4
Contamination 4 4
Material Separation 4 4
Packaging Problem 4 4
Defective Component 3 3
No Apparent Adverse Event 3 3
Detachment of Device or Device Component 3 3
Retraction Problem 3 3
Difficult to Insert 3 3
Component Missing 3 3
Deformation Due to Compressive Stress 2 2
Product Quality Problem 2 2
Infusion or Flow Problem 2 2
Material Twisted/Bent 2 2
Improper Flow or Infusion 2 2
Failure to Align 2 2
Stretched 2 2
Device Markings/Labelling Problem 2 2
Difficult to Advance 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Defective Device 2 2
Gas/Air Leak 1 1
Incomplete or Inadequate Connection 1 1
Device Misassembled During Manufacturing /Shipping 1 1
Particulates 1 1
Restricted Flow rate 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Difficult or Delayed Positioning 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 215 215
Insufficient Information 32 32
No Consequences Or Impact To Patient 12 12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
No Known Impact Or Consequence To Patient 7 7
Low Blood Pressure/ Hypotension 4 4
Air Embolism 3 3
Obstruction/Occlusion 3 3
Foreign Body In Patient 3 3
Hemorrhage/Bleeding 3 3
Abrasion 2 2
Exposure to Body Fluids 2 2
Patient Problem/Medical Problem 1 1
Arrhythmia 1 1
Death 1 1
Cardiac Arrest 1 1
Intracranial Hemorrhage 1 1
Needle Stick/Puncture 1 1
Laceration(s) 1 1
Unspecified Kidney or Urinary Problem 1 1
Bradycardia 1 1
Respiratory Failure 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 Oct-16-2025
4 American Contract Systems, Inc. II Mar-21-2025
5 American Contract Systems, Inc. II Sep-24-2024
6 American Contract Systems, Inc. II Jan-26-2024
7 American Contract Systems, Inc. II Oct-26-2023
8 American Contract Systems, Inc. II Sep-08-2022
9 American Contract Systems, Inc. II May-06-2022
10 Avid Medical, Inc. II Mar-19-2020
11 Cardinal Health 200, LLC II Jul-10-2024
12 MEDLINE INDUSTRIES, LP - Northfield II Apr-17-2025
13 MEDLINE INDUSTRIES, LP - Northfield II Mar-25-2025
14 MEDLINE INDUSTRIES, LP - Northfield II Dec-30-2024
15 MEDLINE INDUSTRIES, LP - Northfield II Dec-20-2024
16 MEDLINE INDUSTRIES, LP - Northfield II Dec-05-2024
17 MEDLINE INDUSTRIES, LP - Northfield II Oct-23-2024
18 MEDLINE INDUSTRIES, LP - Northfield II Aug-28-2024
19 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
20 MEDLINE INDUSTRIES, LP - Northfield I Aug-08-2024
21 MEDLINE INDUSTRIES, LP - Northfield II Jun-28-2024
22 MEDLINE INDUSTRIES, LP - Northfield I Feb-25-2024
23 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
24 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
25 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
26 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
27 ROi CPS LLC II Apr-25-2023
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