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	3
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TAEWOONG MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
TAEWOONG MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3
THORACENT, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation, Positioning or Separation Problem	146	147
Migration	143	147
Activation Failure	77	77
Adverse Event Without Identified Device or Use Problem	73	75
Break	64	67
Detachment of Device or Device Component	63	63
Use of Device Problem	61	61
Improper or Incorrect Procedure or Method	50	55
Material Deformation	45	45
Positioning Problem	45	45
Off-Label Use	35	36
Positioning Failure	33	33
Difficult to Remove	33	33
Activation Problem	29	29
Material Integrity Problem	27	27
Failure to Advance	24	24
Material Twisted/Bent	23	23
Fracture	13	13
Physical Resistance/Sticking	12	13
Premature Activation	10	10
Device Stenosis	9	9
Insufficient Information	7	8
Appropriate Term/Code Not Available	7	7
Obstruction of Flow	6	6
Difficult or Delayed Positioning	6	6
Human-Device Interface Problem	6	6
Material Perforation	5	5
Difficult to Advance	4	4
Material Fragmentation	4	4
Unraveled Material	4	4
Structural Problem	4	4
Component Misassembled	4	4
Device-Device Incompatibility	4	4
Device Markings/Labelling Problem	3	3
Migration or Expulsion of Device	3	3
Wrong Label	2	2
Unsealed Device Packaging	2	2
Difficult to Insert	2	2
Misassembled	2	2
Packaging Problem	2	2
Material Separation	2	2
No Apparent Adverse Event	2	2
Entrapment of Device	2	2
Separation Problem	2	3
Material Puncture/Hole	1	1
Material Erosion	1	1
Defective Component	1	1
Dent in Material	1	2
Reflux within Device	1	1
Product Quality Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	490	495
Obstruction/Occlusion	49	52
Foreign Body In Patient	32	32
Dysphagia/ Odynophagia	31	32
Insufficient Information	20	21
Perforation	17	17
Hemorrhage/Bleeding	16	16
Pain	12	13
Abdominal Pain	12	12
Vomiting	10	10
Discomfort	10	10
Fistula	9	10
Erosion	7	7
Dysphasia	7	7
Ulcer	7	7
Pneumonia	7	8
Nausea	6	6
No Consequences Or Impact To Patient	5	5
Aspiration/Inhalation	5	5
Gastrointestinal Hemorrhage	5	5
Cough	4	4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Unspecified Tissue Injury	3	3
Perforation of Esophagus	3	3
Fever	3	3
Chest Pain	2	2
Bacterial Infection	2	2
Arrhythmia	2	2
Abscess	2	2
Stenosis	2	2
Inflammation	2	2
Laceration(s) of Esophagus	2	2
No Known Impact Or Consequence To Patient	2	2
Decreased Appetite	2	2
Bowel Perforation	2	2
Gastrointestinal Regurgitation	1	1
Hematemesis	1	1
Retroperitoneal Hemorrhage	1	1
Stenosis of the esophagus	1	1
Thrombocytopenia	1	1
Weight Changes	1	1
Intraoperative Pain	1	1
Respiratory Tract Infection	1	1
Laceration(s)	1	1
High Blood Pressure/ Hypertension	1	1
Unspecified Infection	1	1
Sepsis	1	1
Shock	1	1
Tachycardia	1	1
Device Overstimulation of Tissue	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Sep-26-2024