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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device instruments, surgical, cardiovascular
Regulation Description Cardiovascular surgical instruments.
Product CodeDWS
Regulation Number 870.4500
Device Class 1

MDR Year MDR Reports MDR Events
2020 28 28
2021 32 32
2022 35 35
2023 18 18
2024 48 48
2025 12 12
2026 32 32

Device Problems MDRs with this Device Problem Events in those MDRs
Break 42 42
Corroded 20 20
Mechanical Jam 14 14
Physical Resistance/Sticking 11 11
Insufficient Device Problem Information 11 11
Detachment of Device or Device Component 11 11
Mechanical Problem 10 10
Packaging Problem 9 9
Material Fragmentation 6 6
Adverse Event Without Identified Device or Use Problem 6 6
Failure to Cut 5 5
Improper or Incorrect Procedure or Method 5 5
Entrapment of Device 4 4
Dull, Blunt 4 4
Material Integrity Problem 3 3
Material Separation 3 3
Device Markings/Labelling Problem 2 2
Misfire 2 2
Use of Device Problem 2 2
Material Twisted/Bent 2 2
Tear, Rip or Hole in Device Packaging 2 2
Difficult to Open or Close 2 2
Separation Failure 1 1
Difficult to Remove 1 1
No Pressure 1 1
Material Too Rigid or Stiff 1 1
Component Missing 1 1
Difficult or Delayed Activation 1 1
Mechanics Altered 1 1
Delivered as Unsterile Product 1 1
Pitted 1 1
Material Deformation 1 1
Fracture 1 1
Connection Problem 1 1
Failure to Disconnect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 116 116
Insufficient Information 30 30
Foreign Body In Patient 13 13
No Patient Involvement 12 12
No Consequences Or Impact To Patient 10 10
No Known Impact Or Consequence To Patient 5 5
Vascular Dissection 4 4
Unspecified Tissue Injury 4 4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 4 4
Laceration(s) 3 3
Perforation of Vessels 3 3
Cardiac Perforation 2 2
Unspecified Infection 1 1
Intraoperative Cardiac Injury 1 1
No Information 1 1
Hematoma 1 1
Rupture 1 1
Blood Loss 1 1
Cardiac Tamponade 1 1
Thrombosis/Thrombus 1 1
Hemorrhage/Blood Loss/Bleeding 1 1
Great Vessel Perforation 1 1
Unspecified Vascular Problem 1 1
Low Blood Pressure/ Hypotension 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cook Vandergrift, Inc. II Sep-01-2023
2 Deroyal Industries, Inc. Lafollette II Feb-19-2020
3 Galt Medical Corporation II May-07-2025
4 Maquet Cardiovascular, LLC II Jul-31-2023
5 Maquet Cardiovascular, LLC II Apr-12-2022
6 TELEFLEX MEDICAL INC II Jan-27-2020
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