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
1. K221843 GEM Biover Microvascular Clamps
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	679	679
Activation Problem	351	351
Gas/Air Leak	306	306
Deflation Problem	234	234
Failure to Unfold or Unwrap	159	159
Break	97	97
Difficult to Open or Close	97	97
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	36	36
Mechanical Problem	34	34
Material Rupture	32	32
Unintended Deflation	31	31
Detachment of Device or Device Component	30	30
No Apparent Adverse Event	30	30
Premature Activation	24	24
Appropriate Term/Code Not Available	24	24
Material Puncture/Hole	23	23
Failure to Seal	19	19
Burst Container or Vessel	16	16
Material Twisted/Bent	15	15
Material Separation	15	15
Fluid/Blood Leak	13	13
Filling Problem	11	11
Use of Device Problem	10	10
Unintended Movement	9	9
Device Slipped	9	9
Migration	9	9
Defective Device	9	9
Decrease in Pressure	8	8
Failure to Cut	8	8
Difficult to Insert	7	7
Device Contamination with Chemical or Other Material	6	6
Therapeutic or Diagnostic Output Failure	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Component Missing	6	6
Delivered as Unsterile Product	6	6
Physical Resistance/Sticking	5	5
Device Dislodged or Dislocated	5	5
Material Deformation	5	5
Misfire	5	5
Failure to Fire	5	5
Material Split, Cut or Torn	4	4
Patient Device Interaction Problem	4	4
Loose or Intermittent Connection	4	4
Failure to Advance	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1344	1344
No Consequences Or Impact To Patient	553	553
Hematoma	165	165
Hemorrhage/Bleeding	156	156
No Known Impact Or Consequence To Patient	103	103
Insufficient Information	97	97
Blood Loss	69	69
No Patient Involvement	59	59
Pain	16	16
Injury	12	12
No Information	10	10
Bruise/Contusion	10	10
Death	9	9
Foreign Body In Patient	8	8
Pseudoaneurysm	7	7
Swelling/ Edema	6	6
Laceration(s)	5	5
Numbness	5	5
Nerve Damage	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Unspecified Infection	4	4
Cyanosis	3	3
Cardiac Arrest	3	3
Vascular Dissection	3	3
No Code Available	3	3
Perforation of Vessels	3	3
Ventricular Fibrillation	3	3
Thrombosis/Thrombus	3	3
Necrosis	3	3
Nervous System Injury	2	2
Diminished Pulse Pressure	2	2
Rupture	2	2
Failure of Implant	2	2
Cardiovascular Insufficiency	2	2
Unspecified Heart Problem	2	2
Patient Problem/Medical Problem	1	1
Tissue Breakdown	1	1
Device Embedded In Tissue or Plaque	1	1
Multiple Organ Failure	1	1
Embolism/Embolus	1	1
Ascites	1	1
Heart Failure/Congestive Heart Failure	1	1
Unspecified Tissue Injury	1	1
Easy Bruising	1	1
Blister	1	1
Muscle/Tendon Damage	1	1
Hypoxia	1	1
Low Blood Pressure/ Hypotension	1	1
Burn(s)	1	1
Bradycardia	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