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 Code	OWQ
Regulation Number	870.1200
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	3
INNOVATIVE HEALTH, LLC
	SUBSTANTIALLY EQUIVALENT	1
INNOVATIVE HEALTH, LLC.
	SUBSTANTIALLY EQUIVALENT	2
NORTHEAST SCIENTIFIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
STERILMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER SUSTAINABILITY SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	2
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC.
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL INSTRUMENT SERVICES AND SAVINGS, INC
	SUBSTANTIALLY EQUIVALENT	1
VEIN 360 LLC
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fracture	34	34
Poor Quality Image	28	28
Contamination /Decontamination Problem	12	12
Break	11	11
No Display/Image	9	9
Tear, Rip or Hole in Device Packaging	9	9
Material Twisted/Bent	8	8
Patient Device Interaction Problem	7	7
Defective Device	6	6
Material Separation	6	6
Delivered as Unsterile Product	5	5
Therapeutic or Diagnostic Output Failure	3	3
Use of Device Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Erratic or Intermittent Display	2	2
Communication or Transmission Problem	2	2
Device Sensing Problem	2	2
Connection Problem	2	2
Appropriate Term/Code Not Available	1	1
Protective Measures Problem	1	1
Mechanical Jam	1	1
Device Displays Incorrect Message	1	1
Signal Artifact/Noise	1	1
Defective Component	1	1
Positioning Problem	1	1
Expiration Date Error	1	1
Packaging Problem	1	1
Calibration Problem	1	1
Output Problem	1	1
Physical Resistance/Sticking	1	1
Image Display Error/Artifact	1	1
Collapse	1	1
Positioning Failure	1	1
Sharp Edges	1	1
Device Contamination with Chemical or Other Material	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	93	93
No Consequences Or Impact To Patient	25	25
Insufficient Information	10	10
Cardiac Tamponade	6	6
No Known Impact Or Consequence To Patient	6	6
Cardiac Perforation	4	4
No Information	2	2
Air Embolism	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Perforation	1	1
Pericardial Effusion	1	1
Foreign Body In Patient	1	1
Hypoxia	1	1
Heart Block	1	1
Low Blood Pressure/ Hypotension	1	1

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