TPLC - Total Product Life Cycle

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Device	aspiration thrombectomy catheter
Regulation Description	Embolectomy catheter.
Definition	To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
Product Code	QEZ
Regulation Number	870.5150
Device Class	2

Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	4
CONTROL MEDICAL TECHNOLOGY, INC. / DBA VENTIV SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
EXPANSE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
INQUIS MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
KANEKA MEDICAL AMERICA, LLC
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VESALIO, INC.
	SUBSTANTIALLY EQUIVALENT	1
WALK VASCULAR, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	30	30
Difficult to Advance	7	7
Device Dislodged or Dislocated	4	4
Physical Resistance/Sticking	3	3
Difficult to Remove	3	3
Material Deformation	3	3
Material Separation	3	3
Detachment of Device or Device Component	3	3
Suction Failure	2	2
Contamination /Decontamination Problem	2	2
Difficult to Insert	2	2
Device Damaged by Another Device	2	2
No Apparent Adverse Event	2	2
Migration	2	2
Suction Problem	2	2
Deformation Due to Compressive Stress	2	2
Material Frayed	1	1
Material Split, Cut or Torn	1	1
Separation Problem	1	1
Break	1	1
Entrapment of Device	1	1
Mechanical Problem	1	1
Insufficient Information	1	1
Electro-Static Discharge	1	1
Expiration Date Error	1	1
Incorrect, Inadequate or Imprecise Result or Readings	1	1
Air/Gas in Device	1	1
Material Twisted/Bent	1	1
Decrease in Pressure	1	1
Device Handling Problem	1	1
Activation Failure	1	1
Fracture	1	1
Increase in Pressure	1	1
Power Problem	1	1
Loose or Intermittent Connection	1	1
Improper or Incorrect Procedure or Method	1	1
Fluid/Blood Leak	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	19	19
Pulmonary Embolism	15	15
Foreign Body In Patient	7	7
Cardiac Arrest	5	5
Hemorrhage/Bleeding	5	5
Insufficient Information	5	5
Embolism/Embolus	5	5
Thrombosis/Thrombus	3	3
Hematoma	3	3
Low Blood Pressure/ Hypotension	2	2
Decreased Respiratory Rate	2	2
Non specific EKG/ECG Changes	2	2
Perforation of Vessels	2	2
Cardiac Tamponade	2	2
Obstruction/Occlusion	1	1
Fever	1	1
Cardiac Perforation	1	1
Diminished Pulse Pressure	1	1
Pericardial Effusion	1	1
Tics/Tremor	1	1
Hypovolemic Shock	1	1
Infiltration into Tissue	1	1
Renal Failure	1	1
Tachycardia	1	1
Stroke/CVA	1	1
Air Embolism	1	1
Anemia	1	1
Unspecified Vascular Problem	1	1
Heart Failure/Congestive Heart Failure	1	1