TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	7
COOK IRELAND LTD
	SUBSTANTIALLY EQUIVALENT	1
COOK IRELAND LTD.
	SUBSTANTIALLY EQUIVALENT	1
ENDOCHOICE, INC.
	SUBSTANTIALLY EQUIVALENT	1
M.I. TECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
M.I. TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
M.I.TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO.,LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAEWOONG MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TAEWOONG MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	4
TAEWOONG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THORACENT, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation, Positioning or Separation Problem	416	416
Activation Failure	202	202
Migration	140	140
Adverse Event Without Identified Device or Use Problem	133	133
Break	131	131
Positioning Problem	115	115
Migration or Expulsion of Device	112	112
Detachment of Device or Device Component	79	79
Difficult to Remove	79	79
Activation Problem	75	75
Material Deformation	74	74
Use of Device Problem	61	61
Positioning Failure	58	58
Material Integrity Problem	50	50
Improper or Incorrect Procedure or Method	48	48
Fracture	42	42
Insufficient Information	32	32
Off-Label Use	27	27
Failure to Advance	24	24
Appropriate Term/Code Not Available	24	24
Partial Blockage	21	21
Premature Activation	20	20
Material Twisted/Bent	16	16
Physical Resistance/Sticking	14	14
Detachment Of Device Component	11	11
Obstruction of Flow	11	11
Material Perforation	11	11
Difficult or Delayed Positioning	10	10
Device Stenosis	8	8
Human-Device Interface Problem	8	8
Material Separation	8	8
Unraveled Material	8	8
Component Missing	8	8
Difficult to Advance	7	7
Structural Problem	6	6
Kinked	5	5
Torn Material	5	5
Device Markings/Labelling Problem	5	5
Difficult to Open or Close	5	5
Hole In Material	5	5
Device Operates Differently Than Expected	4	4
Knotted	4	4
Device Issue	4	4
Unsealed Device Packaging	3	3
Delivery System Failure	3	3
Device-Device Incompatibility	3	3
Bent	3	3
Infusion or Flow Problem	3	3
Device Dislodged or Dislocated	2	2
Device Or Device Fragments Location Unknown	2	2

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	591	592
No Clinical Signs, Symptoms or Conditions	364	364
No Known Impact Or Consequence To Patient	132	132
Dysphagia/ Odynophagia	57	57
No Code Available	50	50
Obstruction/Occlusion	50	50
Hemorrhage/Bleeding	45	45
Death	36	36
Perforation	35	35
Pain	24	24
Erosion	23	23
Foreign Body In Patient	19	19
Fistula	19	19
Vomiting	18	18
Insufficient Information	14	14
Discomfort	13	13
No Information	11	11
Abdominal Pain	10	10
Dysphasia	10	10
Pneumonia	10	10
Chest Pain	9	9
Nausea	9	9
Fever	8	8
Blood Loss	8	8
Failure of Implant	7	7
Occlusion	7	7
Aspiration/Inhalation	7	7
Gastrointestinal Hemorrhage	5	5
Perforation of Esophagus	5	5
Ulcer	5	5
Regurgitation	5	5
Injury	4	4
No Patient Involvement	4	4
Foreign body, removal of	4	4
Laceration(s) of Esophagus	3	3
Dyspnea	3	3
Cough	3	3
Peritonitis	3	3
Tissue Damage	3	3
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	3	3
Stenosis	2	2
Airway Obstruction	2	2
Internal Organ Perforation	2	2
Difficulty Chewing	2	2
Excessive Tear Production	2	2
Device Embedded In Tissue or Plaque	2	2
Decreased Appetite	2	2
Cardiac Arrest	2	2
Abrasion	2	2
Surgery, prolonged	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Aug-31-2010
2	Boston Scientific Corporation	II	Jun-25-2010
3	Taewoong Medical Co., Ltd.	II	Feb-14-2020