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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
2020 64 64
2021 54 54
2022 81 81
2023 56 56
2024 62 62

Device Problems MDRs with this Device Problem Events in those MDRs
Unsealed Device Packaging 116 116
Tear, Rip or Hole in Device Packaging 86 86
No Apparent Adverse Event 26 26
Material Separation 21 21
Material Frayed 15 15
Adverse Event Without Identified Device or Use Problem 8 8
Appropriate Term/Code Not Available 7 7
Fluid/Blood Leak 7 7
Material Integrity Problem 6 6
Connection Problem 6 6
Break 5 5
Contamination /Decontamination Problem 5 5
Material Fragmentation 5 5
Fracture 5 5
Degraded 4 4
Contamination 3 3
Leak/Splash 2 2
Mechanical Problem 2 2
Defective Component 2 2
Packaging Problem 2 2
Malposition of Device 1 1
Physical Resistance/Sticking 1 1
Crack 1 1
Material Puncture/Hole 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Air/Gas in Device 1 1
Material Discolored 1 1
Component Missing 1 1
Gas/Air Leak 1 1
Product Quality Problem 1 1
Device Contamination with Chemical or Other Material 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 280 280
No Known Impact Or Consequence To Patient 6 6
Insufficient Information 6 6
Air Embolism 5 5
Foreign Body In Patient 5 5
No Consequences Or Impact To Patient 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Reaction 2 2
Hemorrhage/Bleeding 2 2
Perforation 1 1
No Patient Involvement 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 Oct-23-2024
9 MEDLINE INDUSTRIES, LP - Northfield II Aug-27-2024
10 MEDLINE INDUSTRIES, LP - Northfield II Aug-03-2023
11 MEDLINE INDUSTRIES, LP - Northfield II Jul-20-2023
12 MEDLINE INDUSTRIES, LP - Northfield II Feb-10-2023
13 MEDLINE INDUSTRIES, LP - Northfield II Feb-06-2023
14 Medline Industries Inc II Oct-07-2020
15 Merit Medical Systems, Inc. II Oct-11-2024
16 Merit Medical Systems, Inc. II Sep-20-2024
17 Merit Medical Systems, Inc. II Aug-12-2024
18 Merit Medical Systems, Inc. II Dec-29-2020
19 Merit Medical Systems, Inc. II Apr-13-2020
20 ROi CPS LLC II Sep-17-2024
21 Stradis Medical, LLC dba Stradis Healthcare II Dec-14-2022
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