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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device reprocessed intravascular ultrasound catheter
Definition For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Product CodeOWQ
Regulation Number 870.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
INNOVATIVE HEALTH, LLC
  SUBSTANTIALLY EQUIVALENT 1
INNOVATIVE HEALTH, LLC.
  SUBSTANTIALLY EQUIVALENT 5
STERILMED, INC.
  SUBSTANTIALLY EQUIVALENT 1
STRYKER SUSTAINABILITY SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2017 2 2
2018 2 2
2019 9 9
2020 29 29
2021 38 38
2022 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Poor Quality Image 26 26
Fracture 24 24
Material Twisted/Bent 6 6
Adverse Event Without Identified Device or Use Problem 5 5
Break 5 5
No Display/Image 5 5
Tear, Rip or Hole in Device Packaging 5 5
Defective Device 5 5
Delivered as Unsterile Product 3 3
Material Separation 3 3
Use of Device Problem 3 3
Therapeutic or Diagnostic Output Failure 3 3
Contamination /Decontamination Problem 2 2
Communication or Transmission Problem 2 2
Connection Problem 2 2
Device Sensing Problem 2 2
Device Contamination with Chemical or Other Material 1 1
Device Displays Incorrect Message 1 1
Calibration Problem 1 1
Expiration Date Error 1 1
Defective Component 1 1
Radio Signal Problem 1 1
Signal Artifact/Noise 1 1
Erratic or Intermittent Display 1 1
Appropriate Term/Code Not Available 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 45 45
No Consequences Or Impact To Patient 27 27
Insufficient Information 9 9
No Known Impact Or Consequence To Patient 6 6
Cardiac Tamponade 4 4
Cardiac Perforation 2 2
No Information 2 2
Pericardial Effusion 2 2
Not Applicable 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Northeast Scientific Inc. II Aug-23-2021
2 Stryker Sustainability Solutions II Jun-01-2020
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