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	649	649
Activation Problem	346	346
Gas/Air Leak	295	295
Deflation Problem	229	229
Failure to Unfold or Unwrap	156	156
Difficult to Open or Close	96	96
Break	95	95
Adverse Event Without Identified Device or Use Problem	91	91
Leak/Splash	64	64
Insufficient Information	63	63
Crack	61	61
Inflation Problem	46	46
Unraveled Material	34	34
Activation, Positioning or Separation Problem	33	33
Mechanical Problem	32	32
Material Rupture	31	31
No Apparent Adverse Event	30	30
Detachment of Device or Device Component	30	30
Unintended Deflation	25	25
Appropriate Term/Code Not Available	24	24
Material Puncture/Hole	23	23
Premature Activation	22	22
Failure to Seal	16	16
Burst Container or Vessel	16	16
Material Separation	15	15
Material Twisted/Bent	12	12
Filling Problem	11	11
Fluid/Blood Leak	10	10
Device Slipped	9	9
Migration	9	9
Unintended Movement	9	9
Defective Device	9	9
Failure to Cut	8	8
Decrease in Pressure	8	8
Use of Device Problem	8	8
Difficult to Insert	7	7
Device Contamination with Chemical or Other Material	6	6
Delivered as Unsterile Product	6	6
Component Missing	6	6
Therapeutic or Diagnostic Output Failure	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Device Dislodged or Dislocated	5	5
Misfire	5	5
Failure to Fire	5	5
Material Deformation	5	5
Physical Resistance/Sticking	5	5
Failure to Advance	4	4
Patient Device Interaction Problem	4	4
Loose or Intermittent Connection	4	4
Material Split, Cut or Torn	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1284	1284
No Consequences Or Impact To Patient	553	553
Hematoma	157	157
Hemorrhage/Bleeding	147	147
No Known Impact Or Consequence To Patient	103	103
Insufficient Information	89	89
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
Pseudoaneurysm	7	7
Foreign Body In Patient	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
Thrombosis/Thrombus	3	3
Ventricular Fibrillation	3	3
Cardiac Arrest	3	3
Cyanosis	3	3
Vascular Dissection	3	3
Necrosis	3	3
No Code Available	3	3
Rupture	2	2
Diminished Pulse Pressure	2	2
Nerve Damage	2	2
Numbness	2	2
Unspecified Heart Problem	2	2
Failure of Implant	2	2
Device Embedded In Tissue or Plaque	1	1
Intimal Dissection	1	1
Nervous System Injury	1	1
Low Blood Pressure/ Hypotension	1	1
Ascites	1	1
Loss of consciousness	1	1
Air Embolism	1	1
Patient Problem/Medical Problem	1	1
Skin Tears	1	1
Tissue Damage	1	1
Hypoxia	1	1
Unspecified Tissue Injury	1	1
Perforation of Vessels	1	1
Renal Failure	1	1
Heart Failure/Congestive Heart Failure	1	1
Bradycardia	1	1
Failure to Anastomose	1	1
Respiratory Distress	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