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	2
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	38	38
Poor Quality Image	25	25
Contamination /Decontamination Problem	19	19
Delivered as Unsterile Product	13	13
Break	12	12
Packaging Problem	11	11
Tear, Rip or Hole in Device Packaging	11	11
Material Separation	10	10
Patient Device Interaction Problem	9	9
Material Twisted/Bent	9	9
No Display/Image	8	8
Defective Device	6	6
Use of Device Problem	4	4
Adverse Event Without Identified Device or Use Problem	4	4
Mechanical Jam	4	4
Positioning Problem	3	3
Therapeutic or Diagnostic Output Failure	3	3
Communication or Transmission Problem	2	2
Insufficient Information	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
Device Contamination with Body Fluid	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 Failure	1	1
Sharp Edges	1	1
Calibration 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

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	135	135
No Consequences Or Impact To Patient	20	20
Insufficient Information	10	10
Cardiac Tamponade	8	8
Cardiac Perforation	7	7
No Known Impact Or Consequence To Patient	4	4
Pericardial Effusion	3	3
Unspecified Infection	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
Hypoxia	1	1
Heart Block	1	1
Low Blood Pressure/ Hypotension	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Medline Industries, LP	I	Sep-26-2025
2	Northeast Scientific Inc.	II	Aug-23-2021
3	Stryker Sustainability Solutions	II	Jun-01-2020