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	139	140
Migration	137	141
Activation Failure	75	75
Adverse Event Without Identified Device or Use Problem	71	73
Detachment of Device or Device Component	62	62
Use of Device Problem	61	61
Break	54	57
Improper or Incorrect Procedure or Method	50	55
Material Deformation	45	45
Positioning Problem	45	45
Off-Label Use	35	36
Difficult to Remove	33	33
Positioning Failure	32	32
Activation Problem	29	29
Material Integrity Problem	27	27
Material Twisted/Bent	23	23
Failure to Advance	22	22
Physical Resistance/Sticking	12	13
Fracture	11	11
Premature Activation	10	10
Device Stenosis	9	9
Insufficient Information	7	8
Appropriate Term/Code Not Available	7	7
Difficult or Delayed Positioning	6	6
Human-Device Interface Problem	6	6
Obstruction of Flow	5	5
Material Perforation	5	5
Unraveled Material	4	4
Difficult to Advance	4	4
Structural Problem	4	4
Component Misassembled	4	4
Device-Device Incompatibility	4	4
Material Fragmentation	3	3
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	471	476
Obstruction/Occlusion	47	50
Dysphagia/ Odynophagia	31	32
Foreign Body In Patient	28	28
Insufficient Information	20	21
Hemorrhage/Bleeding	16	16
Perforation	16	16
Pain	12	13
Discomfort	10	10
Fistula	9	10
Vomiting	9	9
Abdominal Pain	8	8
Pneumonia	7	8
Dysphasia	7	7
Erosion	7	7
Ulcer	7	7
Nausea	6	6
Aspiration/Inhalation	5	5
Gastrointestinal Hemorrhage	5	5
No Consequences Or Impact To Patient	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
Inflammation	2	2
Bacterial Infection	2	2
Laceration(s) of Esophagus	2	2
Bowel Perforation	2	2
No Known Impact Or Consequence To Patient	2	2
Fever	2	2
Chest Pain	2	2
Arrhythmia	2	2
Abscess	2	2
Decreased Appetite	2	2
Thrombocytopenia	1	1
Feeding Problem	1	1
Stenosis	1	1
Tachycardia	1	1
Shock	1	1
Airway Obstruction	1	2
Gastrointestinal Regurgitation	1	1
Cardiomyopathy	1	1
Hematemesis	1	1
Laceration(s)	1	1
Dyspnea	1	1
Respiratory Tract Infection	1	1
Stenosis of the esophagus	1	1
Retroperitoneal Hemorrhage	1	1
Device Overstimulation of Tissue	1	1
Cellulitis	1	1

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