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	628	628
Activation Problem	338	338
Gas/Air Leak	287	287
Deflation Problem	221	221
Failure to Unfold or Unwrap	154	154
Difficult to Open or Close	100	100
Break	92	92
Adverse Event Without Identified Device or Use Problem	91	91
Leak/Splash	61	61
Insufficient Information	61	61
Crack	61	61
Inflation Problem	46	46
Unraveled Material	33	33
Activation, Positioning or Separation Problem	32	32
Mechanical Problem	31	31
Material Rupture	30	30
No Apparent Adverse Event	30	30
Detachment of Device or Device Component	29	29
Appropriate Term/Code Not Available	24	24
Material Puncture/Hole	23	23
Unintended Deflation	23	23
Premature Activation	22	22
Burst Container or Vessel	16	16
Failure to Seal	15	15
Material Separation	15	15
Material Twisted/Bent	12	12
Filling Problem	11	11
Fluid/Blood Leak	10	10
Defective Device	9	9
Device Slipped	9	9
Migration	9	9
Unintended Movement	9	9
Use of Device Problem	8	8
Decrease in Pressure	8	8
Failure to Cut	8	8
Difficult to Insert	7	7
Component Missing	6	6
Therapeutic or Diagnostic Output Failure	6	6
Manufacturing, Packaging or Shipping Problem	6	6
Delivered as Unsterile Product	6	6
Device Contamination with Chemical or Other Material	6	6
Physical Resistance/Sticking	5	5
Failure to Fire	5	5
Material Deformation	5	5
Misfire	5	5
Patient Device Interaction Problem	4	4
Peeled/Delaminated	4	4
Material Split, Cut or Torn	4	4
Failure to Advance	4	4
Loose or Intermittent Connection	4	4

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	1240	1240
No Consequences Or Impact To Patient	553	553
Hematoma	153	153
Hemorrhage/Bleeding	142	142
No Known Impact Or Consequence To Patient	103	103
Insufficient Information	83	83
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
Cardiac Arrest	3	3
Ventricular Fibrillation	3	3
Necrosis	3	3
Vascular Dissection	3	3
Thrombosis/Thrombus	3	3
No Code Available	3	3
Cyanosis	3	3
Diminished Pulse Pressure	2	2
Rupture	2	2
Unspecified Heart Problem	2	2
Failure of Implant	2	2
Numbness	2	2
Nerve Damage	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
Hypoxia	1	1
Tissue Damage	1	1
Perforation of Vessels	1	1
Unspecified Tissue Injury	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