TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
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	152	153
Migration	143	147
Activation Failure	86	86
Adverse Event Without Identified Device or Use Problem	79	81
Break	67	70
Detachment of Device or Device Component	64	64
Use of Device Problem	63	63
Improper or Incorrect Procedure or Method	51	56
Positioning Problem	48	48
Material Deformation	46	46
Off-Label Use	35	36
Positioning Failure	35	35
Difficult to Remove	34	34
Activation Problem	29	29
Material Integrity Problem	29	29
Failure to Advance	26	26
Material Twisted/Bent	24	24
Fracture	17	17
Physical Resistance/Sticking	17	18
Premature Activation	11	11
Device Stenosis	9	9
Insufficient Device Problem Information	7	8
Appropriate Device Problem Term/Code Not Available	7	7
Material Fragmentation	6	6
Obstruction of Flow	6	6
Difficult or Delayed Positioning	6	6
Human-Device Interface Problem	6	6
Difficult to Advance	5	5
Material Perforation	5	5
Unraveled Material	4	4
Structural Problem	4	4
Device Markings/Labelling Problem	4	4
Component Misassembled	4	4
Migration or Expulsion of Device	4	4
Device-Device Incompatibility	4	4
Material Separation	3	3
Deformation Due to Compressive Stress	3	3
Unsealed Device Packaging	2	2
Wrong Label	2	2
Difficult to Insert	2	2
Separation Failure	2	2
Misassembled	2	2
Packaging Problem	2	2
No Apparent Adverse Event	2	2
Malposition of Device	2	2
Separation Problem	2	3
Device Dislodged or Dislocated	2	2
Material Puncture/Hole	1	1
Failure to Deliver	1	1
Device Misassembled During Manufacturing /Shipping	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	526	531
Obstruction/Occlusion	49	52
Foreign Body In Patient	34	34
Dysphagia/ Odynophagia	31	32
Insufficient Information	22	23
Perforation	18	18
Hemorrhage/Blood Loss/Bleeding	16	16
Pain	13	14
Abdominal Pain	12	12
Discomfort	10	10
Vomiting	10	10
Biliary Leak	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 and Conditions Term/Code Not Available	4	4
Cough	4	4
Unspecified Tissue Injury	3	3
Perforation of Esophagus	3	3
Fever	3	3
Decreased Appetite	2	2
Bacterial Infection	2	2
Stenosis	2	2
Abscess	2	2
Pneumoperitoneum	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
Respiratory Tract Infection	1	1
Device Overstimulation of Tissue	1	1
Dyspnea	1	1
Cellulitis	1	1
Laceration(s)	1	1
Hematemesis	1	1
Anemia	1	1
Cardiomyopathy	1	1
Gastrointestinal Regurgitation	1	1
Hemoptysis	1	1
Shock	1	1

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