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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device angiography/angioplasty 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 CodeOEQ
Regulation Number 870.1650
Device Class 2

MDR Year MDR Reports MDR Events
2019 22 22
2020 64 64
2021 54 54
2022 81 81
2023 56 56
2024 48 48

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 113 113
Tear, Rip or Hole in Device Packaging 85 85
No Apparent Adverse Event 26 26
Material Separation 24 24
Material Frayed 15 15
Contamination /Decontamination Problem 9 9
Adverse Event Without Identified Device or Use Problem 8 8
Material Integrity Problem 7 7
Appropriate Term/Code Not Available 7 7
Fluid/Blood Leak 7 7
Fracture 6 6
Break 5 5
Material Fragmentation 5 5
Degraded 4 4
Device Contamination with Chemical or Other Material 4 4
Connection Problem 4 4
Contamination 3 3
Packaging Problem 3 3
Leak/Splash 2 2
Mechanical Problem 2 2
Crack 2 2
Defective Component 2 2
Device Contaminated During Manufacture or Shipping 1 1
Malposition of Device 1 1
Physical Resistance/Sticking 1 1
Material Puncture/Hole 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Air/Gas in Device 1 1
Unraveled Material 1 1
Material Discolored 1 1
Component Missing 1 1
Gas/Air Leak 1 1
Material Deformation 1 1
Product Quality Problem 1 1
Detachment of Device or Device Component 1 1
Material Protrusion/Extrusion 1 1
Component Misassembled 1 1
Dull, Blunt 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 266 266
No Known Impact Or Consequence To Patient 12 12
No Patient Involvement 10 10
No Consequences Or Impact To Patient 9 9
Foreign Body In Patient 8 8
Insufficient Information 6 6
Air Embolism 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Reaction 2 2
Hemorrhage/Bleeding 2 2
Perforation 1 1
Perforation of Vessels 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 American Contract Systems II May-29-2020
2 American Contract Systems, Inc. II Sep-24-2024
3 American Contract Systems, Inc. II Aug-07-2024
4 American Contract Systems, Inc. II Sep-08-2022
5 Cardinal Health 200, LLC II Jul-10-2024
6 Cardinal Health 200, LLC II Mar-15-2021
7 DeRoyal Industries Inc II Jul-03-2023
8 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
10 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
13 Medline Industries Inc II Oct-07-2020
14 Merit Medical Systems, Inc. II Sep-20-2024
15 Merit Medical Systems, Inc. II Aug-12-2024
16 Merit Medical Systems, Inc. II Dec-29-2020
17 Merit Medical Systems, Inc. II Apr-13-2020
18 Merit Medical Systems, Inc. II Oct-01-2019
19 ROi CPS LLC II Sep-17-2024
20 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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