TPLC - Total Product Life Cycle

show TPLC since

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	2
NORTHEAST SCIENTIFIC, INC.
	SUBSTANTIALLY EQUIVALENT	1
STRYKER SUSTAINABILITY SOLUTIONS
	SUBSTANTIALLY EQUIVALENT	1
SURGICAL INSTRUMENT SERVICE AND SAVINGS INC.
	SUBSTANTIALLY EQUIVALENT	2
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	36	36
Poor Quality Image	23	23
Contamination /Decontamination Problem	17	17
Break	12	12
Tear, Rip or Hole in Device Packaging	10	10
Patient Device Interaction Problem	9	9
No Display/Image	8	8
Material Twisted/Bent	8	8
Material Separation	7	7
Defective Device	6	6
Therapeutic or Diagnostic Output Failure	3	3
Use of Device Problem	3	3
Adverse Event Without Identified Device or Use Problem	3	3
Delivered as Unsterile Product	3	3
Communication or Transmission Problem	2	2
Erratic or Intermittent Display	2	2
Appropriate Term/Code Not Available	2	2
Connection Problem	2	2
Signal Artifact/Noise	1	1
Material Split, Cut or Torn	1	1
Output Problem	1	1
Physical Resistance/Sticking	1	1
Image Display Error/Artifact	1	1
Collapse	1	1
Defective Component	1	1
Expiration Date Error	1	1
Positioning Problem	1	1
Positioning Failure	1	1
Sharp Edges	1	1
Calibration Problem	1	1
Packaging Problem	1	1
Detachment of Device or Device Component	1	1
Device Sensing Problem	1	1
Protective Measures Problem	1	1
Device Displays Incorrect Message	1	1
Deformation Due to Compressive Stress	1	1
Mechanical Jam	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	112	112
No Consequences Or Impact To Patient	20	20
Insufficient Information	10	10
Cardiac Tamponade	7	7
No Known Impact Or Consequence To Patient	4	4
Cardiac Perforation	4	4
Unspecified Infection	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
Pleural Effusion	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