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TPLC
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Device
catheter, pressure monitoring, cardiac
Definition
To measure pressure within the cardiovascular system.
Product Code
OBI
Regulation Number
870.1200
Device Class
2
Premarket Reviews
Manufacturer
Decision
ACIST MEDICAL SYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
2
2
2017
2
2
2018
1
1
2019
2
2
2021
1
1
2022
11
11
2023
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Defective Device
8
8
Adverse Event Without Identified Device or Use Problem
4
4
Insufficient Information
3
3
Break
3
3
Air Leak
1
1
Detachment of Device or Device Component
1
1
Device Operates Differently Than Expected
1
1
Device Damaged by Another Device
1
1
Device Contamination with Chemical or Other Material
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Respiratory Insufficiency
8
8
No Clinical Signs, Symptoms or Conditions
4
4
Vascular Dissection
4
4
Embolism/Embolus
1
1
Stroke/CVA
1
1
No Consequences Or Impact To Patient
1
1
Thromboembolism
1
1
No Known Impact Or Consequence To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Merit Medical Systems, Inc.
II
Apr-03-2014
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