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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
2019 28 28
2020 28 28
2021 32 32
2022 35 35
2023 18 18
2024 48 48
2025 11 11

Device Problems MDRs with this Device Problem Events in those MDRs
Break 45 45
Corroded 23 23
Mechanical Jam 15 15
Physical Resistance/Sticking 13 13
Adverse Event Without Identified Device or Use Problem 13 13
Mechanical Problem 10 10
Detachment of Device or Device Component 9 9
Failure to Cut 8 8
Insufficient Information 7 7
Material Fragmentation 6 6
Packaging Problem 5 5
Material Separation 5 5
Entrapment of Device 4 4
Improper or Incorrect Procedure or Method 4 4
Material Integrity Problem 3 3
Component Missing 3 3
Fracture 3 3
Difficult to Open or Close 3 3
Dull, Blunt 3 3
Leak/Splash 2 2
Device Markings/Labelling Problem 2 2
Difficult to Remove 2 2
Misfire 2 2
Crack 1 1
Material Erosion 1 1
Separation Failure 1 1
Device Fell 1 1
No Pressure 1 1
Material Too Rigid or Stiff 1 1
Use of Device Problem 1 1
Difficult or Delayed Activation 1 1
Material Perforation 1 1
Mechanics Altered 1 1
Delivered as Unsterile Product 1 1
Pitted 1 1
Loose or Intermittent Connection 1 1
Failure to Disconnect 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 101 101
Insufficient Information 23 23
No Patient Involvement 18 18
No Consequences Or Impact To Patient 18 18
No Information 10 10
Foreign Body In Patient 9 9
No Known Impact Or Consequence To Patient 8 8
Tissue Damage 8 8
Vascular Dissection 4 4
Perforation of Vessels 4 5
Unspecified Tissue Injury 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Laceration(s) 3 3
Cardiac Perforation 2 2
Death 1 1
Blood Loss 1 1
Rupture 1 1
Cardiac Tamponade 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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