TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BEIJING DEMAX MEDICAL TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
BIOREP TECHNOLOGIES, INC
	SUBSTANTIALLY EQUIVALENT	1
CAREFUSION 2200 INC
	SUBSTANTIALLY EQUIVALENT	1
COMPRESSION WORKS INC
	SUBSTANTIALLY EQUIVALENT	1
ENSITE VACULAR, LLC
	SUBSTANTIALLY EQUIVALENT	1
ENSITE VASCULAR
	SUBSTANTIALLY EQUIVALENT	2
KONO SEISAKUSHO CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
MEDICAL INGENUITIES
	SUBSTANTIALLY EQUIVALENT	1
NINGBO DIZEGENS MEDICAL SCIENCE CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SUNNY MEDICAL DEVICE (SHENZHEN) CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYNOVIS MICRO COMPANIES ALLIANCE, INC.
	SUBSTANTIALLY EQUIVALENT	1
TERUMO MEDICAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VASCULAR GRAFT SOLUTIONS, LTD.
	SUBSTANTIALLY EQUIVALENT	2
VASOINNOVATIONS INC.
	SUBSTANTIALLY EQUIVALENT	1
VASOINNOVATIONS, INC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Fitting Problem	673	673
Activation Problem	349	349
Gas/Air Leak	301	301
Deflation Problem	234	234
Failure to Unfold or Unwrap	158	158
Difficult to Open or Close	97	97
Break	96	96
Adverse Event Without Identified Device or Use Problem	91	91
Leak/Splash	69	69
Insufficient Information	64	64
Crack	61	61
Inflation Problem	46	46
Unraveled Material	36	36
Activation, Positioning or Separation Problem	35	35
Mechanical Problem	34	34
Material Rupture	32	32
No Apparent Adverse Event	30	30
Detachment of Device or Device Component	30	30
Unintended Deflation	28	28
Premature Activation	24	24
Appropriate Term/Code Not Available	24	24
Material Puncture/Hole	23	23
Failure to Seal	18	18
Burst Container or Vessel	16	16
Material Separation	15	15
Material Twisted/Bent	12	12
Filling Problem	11	11
Fluid/Blood Leak	11	11
Use of Device Problem	10	10
Device Slipped	9	9
Unintended Movement	9	9
Defective Device	9	9
Migration	9	9
Failure to Cut	8	8
Decrease in Pressure	8	8
Difficult to Insert	7	7
Manufacturing, Packaging or Shipping Problem	6	6
Therapeutic or Diagnostic Output Failure	6	6
Device Contamination with Chemical or Other Material	6	6
Delivered as Unsterile Product	6	6
Component Missing	6	6
Device Dislodged or Dislocated	5	5
Failure to Fire	5	5
Material Deformation	5	5
Misfire	5	5
Physical Resistance/Sticking	5	5
Loose or Intermittent Connection	4	4
Material Split, Cut or Torn	4	4
Failure to Advance	4	4
Patient Device Interaction Problem	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1326	1326
No Consequences Or Impact To Patient	553	553
Hematoma	162	162
Hemorrhage/Bleeding	152	152
No Known Impact Or Consequence To Patient	103	103
Insufficient Information	97	97
Blood Loss	69	69
No Patient Involvement	59	59
Pain	15	15
Injury	12	12
Bruise/Contusion	10	10
No Information	10	10
Death	9	9
Foreign Body In Patient	8	8
Pseudoaneurysm	7	7
Swelling/ Edema	6	6
Laceration(s)	5	5
Unspecified Infection	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Cyanosis	3	3
No Code Available	3	3
Vascular Dissection	3	3
Necrosis	3	3
Thrombosis/Thrombus	3	3
Cardiac Arrest	3	3
Ventricular Fibrillation	3	3
Cardiovascular Insufficiency	2	2
Unspecified Heart Problem	2	2
Nerve Damage	2	2
Numbness	2	2
Rupture	2	2
Diminished Pulse Pressure	2	2
Failure of Implant	2	2
Aortic Dissection	1	1
Burn(s)	1	1
Pallor	1	1
Needle Stick/Puncture	1	1
Obstruction/Occlusion	1	1
Blister	1	1
Easy Bruising	1	1
Burn, Thermal	1	1
Discomfort	1	1
Multiple Organ Failure	1	1
Embolism/Embolus	1	1
Failure to Anastomose	1	1
Bradycardia	1	1
Heart Failure/Congestive Heart Failure	1	1
Renal Failure	1	1
Unspecified Tissue Injury	1	1
Perforation of Vessels	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Baxter Healthcare Corporation	II	Apr-12-2024
2	Baxter Healthcare Corporation	II	Jan-05-2024
3	Baxter Healthcare Corporation	II	Apr-29-2022
4	Edwards Lifesciences, LLC	I	Jun-11-2019
5	Edwards Lifesciences, LLC	II	Apr-06-2019
6	Integra LifeSciences Corp.	II	Aug-30-2019
7	Merit Medical Systems, Inc.	II	Apr-24-2020