TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
M.I. TECH CO., LTD
	SUBSTANTIALLY EQUIVALENT	2
M.I.TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
TAEWOONG MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TAEWOONG MEDICAL CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
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	191	191
Migration	131	131
Activation Failure	131	131
Activation Problem	70	70
Detachment of Device or Device Component	64	64
Adverse Event Without Identified Device or Use Problem	56	56
Improper or Incorrect Procedure or Method	51	51
Material Deformation	51	51
Use of Device Problem	51	51
Positioning Problem	50	50
Break	45	45
Positioning Failure	38	38
Off-Label Use	34	34
Difficult to Remove	31	31
Failure to Advance	25	25
Material Twisted/Bent	20	20
Material Integrity Problem	18	18
Physical Resistance/Sticking	16	16
Appropriate Term/Code Not Available	11	11
Fracture	10	10
Difficult or Delayed Positioning	10	10
Premature Activation	8	8
Obstruction of Flow	8	8
Insufficient Information	8	8
Device Stenosis	8	8
Difficult to Advance	7	7
Migration or Expulsion of Device	7	7
Human-Device Interface Problem	7	7
Material Perforation	5	5
Structural Problem	4	4
Unraveled Material	3	3
Unsealed Device Packaging	3	3
Material Separation	3	3
Device Markings/Labelling Problem	3	3
Device-Device Incompatibility	3	3
Difficult to Insert	2	2
Wrong Label	2	2
Misassembled	2	2
Packaging Problem	2	2
No Apparent Adverse Event	2	2
Component Misassembled	2	2
Entrapment of Device	2	2
Separation Problem	2	2
Deformation Due to Compressive Stress	2	2
Defective Component	1	1
Separation Failure	1	1
Material Puncture/Hole	1	1
Dent in Material	1	1
Difficult or Delayed Activation	1	1
Material Erosion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	421	421
No Consequences Or Impact To Patient	103	103
Obstruction/Occlusion	36	36
Dysphagia/ Odynophagia	32	32
Hemorrhage/Bleeding	19	19
Insufficient Information	18	18
No Known Impact Or Consequence To Patient	18	18
No Code Available	14	14
Perforation	14	14
Foreign Body In Patient	13	13
Pain	12	12
Discomfort	10	10
Vomiting	10	10
Erosion	9	9
Dysphasia	7	7
Fistula	7	7
Nausea	7	7
Pneumonia	6	6
Abdominal Pain	6	6
Gastrointestinal Hemorrhage	5	5
Ulcer	5	5
Aspiration/Inhalation	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Cough	4	4
Failure of Implant	3	3
Unspecified Tissue Injury	3	3
Laceration(s) of Esophagus	2	2
Perforation of Esophagus	2	2
Peritonitis	2	2
Fever	2	2
Chest Pain	2	2
Airway Obstruction	2	2
Dyspnea	2	2
Decreased Appetite	2	2
Thrombocytopenia	1	1
Excessive Tear Production	1	1
Skin Tears	1	1
Feeding Problem	1	1
Device Embedded In Tissue or Plaque	1	1
Stenosis	1	1
Tachycardia	1	1
Shock	1	1
Gastrointestinal Regurgitation	1	1
Cardiomyopathy	1	1
Abscess	1	1
Hematemesis	1	1
Laceration(s)	1	1
No Patient Involvement	1	1
Respiratory Tract Infection	1	1
Retroperitoneal Hemorrhage	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Sep-26-2024
2	Taewoong Medical Co., Ltd.	II	Feb-14-2020