TPLC - Total Product Life Cycle

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Device	reprocessed intravascular ultrasound catheter
Regulation Description	Diagnostic intravascular 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
NORTHEAST SCIENTIFIC, INC.
	SUBSTANTIALLY EQUIVALENT	2
STRYKER SUSTAINABILITY SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL INSTRUMENT SERVICE AND SAVINGS, INC.
	SUBSTANTIALLY EQUIVALENT	3
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	39	39
Contamination /Decontamination Problem	21	21
Delivered as Unsterile Product	15	15
Break	12	12
Poor Quality Image	12	12
Packaging Problem	12	12
Material Separation	12	12
No Display/Image	11	11
Material Twisted/Bent	11	11
Patient Device Interaction Problem	9	9
Tear, Rip or Hole in Device Packaging	8	8
Defective Device	6	6
Use of Device Problem	5	5
Adverse Event Without Identified Device or Use Problem	5	5
Mechanical Jam	4	4
Positioning Problem	3	3
Material Split, Cut or Torn	2	2
Communication or Transmission Problem	2	2
Insufficient Information	2	2
Therapeutic or Diagnostic Output Failure	2	2
Erratic or Intermittent Display	2	2
Appropriate Term/Code Not Available	2	2
Device Contamination with Body Fluid	1	1
Output Problem	1	1
Physical Resistance/Sticking	1	1
Image Display Error/Artifact	1	1
Device Damaged Prior to Use	1	1
Collapse	1	1
Difficult to Advance	1	1
Defective Component	1	1
Expiration Date Error	1	1
Difficult to Remove	1	1
Positioning Failure	1	1
Sharp Edges	1	1
Detachment of Device or Device Component	1	1
Device Sensing Problem	1	1
Protective Measures Problem	1	1
Connection Problem	1	1
Device Displays Incorrect Message	1	1
Deformation Due to Compressive Stress	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	151	151
Insufficient Information	10	10
Cardiac Perforation	8	8
Cardiac Tamponade	6	6
Pericardial Effusion	3	3
Unspecified Infection	2	2
Retroperitoneal Hemorrhage	2	2
Low Blood Pressure/ Hypotension	2	2
Air Embolism	1	1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	1	1
Perforation	1	1
Foreign Body In Patient	1	1
Pleural Effusion	1	1
Asystole	1	1
Hypoxia	1	1
Heart Block	1	1