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	147	148
Migration	144	148
Activation Failure	78	78
Adverse Event Without Identified Device or Use Problem	76	78
Break	65	68
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	34	34
Difficult to Remove	33	33
Activation Problem	29	29
Material Integrity Problem	28	28
Failure to Advance	25	25
Material Twisted/Bent	23	23
Fracture	13	13
Physical Resistance/Sticking	12	13
Premature Activation	10	10
Device Stenosis	9	9
Appropriate Term/Code Not Available	7	7
Insufficient Information	7	8
Obstruction of Flow	6	6
Difficult or Delayed Positioning	6	6
Human-Device Interface Problem	6	6
Material Fragmentation	5	5
Material Perforation	5	5
Unraveled Material	4	4
Structural Problem	4	4
Component Misassembled	4	4
Difficult to Advance	4	4
Device-Device Incompatibility	4	4
Migration or Expulsion of Device	3	3
Device Markings/Labelling Problem	3	3
Unsealed Device Packaging	2	2
Difficult to Insert	2	2
Wrong Label	2	2
Misassembled	2	2
Packaging Problem	2	2
Material Separation	2	2
Entrapment of Device	2	2
No Apparent Adverse Event	2	2
Separation Problem	2	3
Defective Component	1	1
Therapeutic or Diagnostic Output Failure	1	1
Reflux within Device	1	1
Dent in Material	1	2
Material Puncture/Hole	1	1
Material Erosion	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	495	500
Obstruction/Occlusion	49	52
Foreign Body In Patient	32	32
Dysphagia/ Odynophagia	31	32
Insufficient Information	21	22
Perforation	18	18
Hemorrhage/Bleeding	16	16
Abdominal Pain	12	12
Pain	12	13
Vomiting	10	10
Discomfort	10	10
Fistula	9	10
Dysphasia	7	7
Erosion	7	7
Ulcer	7	7
Pneumonia	7	8
Nausea	6	6
No Consequences Or Impact To Patient	5	5
Gastrointestinal Hemorrhage	5	5
Aspiration/Inhalation	5	5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	4	4
Cough	4	4
Perforation of Esophagus	3	3
Unspecified Tissue Injury	3	3
Fever	3	3
Decreased Appetite	2	2
Bacterial Infection	2	2
Stenosis	2	2
Abscess	2	2
Chest Pain	2	2
No Known Impact Or Consequence To Patient	2	2
Laceration(s) of Esophagus	2	2
Inflammation	2	2
Bowel Perforation	2	2
Arrhythmia	2	2
Stenosis of the esophagus	1	1
Retroperitoneal Hemorrhage	1	1
Cellulitis	1	1
Device Overstimulation of Tissue	1	1
Respiratory Tract Infection	1	1
Laceration(s)	1	1
Hematemesis	1	1
Dyspnea	1	1
Pyrosis/Heartburn	1	1
Gastrointestinal Regurgitation	1	1
Cardiomyopathy	1	1
Anemia	1	1
Hemoptysis	1	1
Shock	1	1
Tachycardia	1	1

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