TPLC - Total Product Life Cycle

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Device	prosthesis, tracheal, expandable
Product Code	JCT
Regulation Number	878.3720
Device Class	2

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
M.I. TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MICRO-TECH (NANJING) CO., LTD.
	SUBSTANTIALLY EQUIVALENT	3

Device Problems	MDRs with this Device Problem	Events in those MDRs
Activation, Positioning or Separation Problem	126	126
Material Deformation	88	88
Adverse Event Without Identified Device or Use Problem	58	58
Break	48	48
Positioning Problem	42	42
Activation Failure	39	39
Positioning Failure	39	39
Migration	24	24
Use of Device Problem	24	24
Appropriate Term/Code Not Available	19	19
Failure to Advance	18	18
Material Twisted/Bent	17	17
Defective Device	13	13
Leak/Splash	12	12
Unraveled Material	12	12
Difficult to Remove	12	12
Fracture	11	11
Detachment of Device or Device Component	11	11
Device-Device Incompatibility	9	9
Difficult or Delayed Positioning	9	9
Malposition of Device	7	7
Material Separation	7	7
Material Rupture	7	7
Difficult to Advance	7	7
Device Stenosis	6	6
Material Integrity Problem	6	6
Premature Activation	5	5
Device Dislodged or Dislocated	5	5
Obstruction of Flow	5	5
Insufficient Information	5	5
Mechanical Problem	5	5
Human-Device Interface Problem	4	4
Premature Separation	4	4
Device Misassembled During Manufacturing /Shipping	3	3
Migration or Expulsion of Device	3	3
Deformation Due to Compressive Stress	3	3
Material Fragmentation	2	2
Expiration Date Error	2	2
Unsealed Device Packaging	2	2
Separation Failure	2	2
Material Puncture/Hole	2	2
Complete Blockage	2	2
Packaging Problem	2	2
No Apparent Adverse Event	2	2
Off-Label Use	2	2
Entrapment of Device	2	2
Separation Problem	2	2
Difficult to Open or Close	2	2
Ejection Problem	1	1
Stretched	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	266	266
No Consequences Or Impact To Patient	67	67
Obstruction/Occlusion	17	17
Hemorrhage/Bleeding	14	14
Insufficient Information	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Blood Loss	10	10
Death	9	9
No Information	8	8
Occlusion	8	8
Restenosis	6	6
Renal Failure	6	6
Thrombosis/Thrombus	6	6
Stenosis of the esophagus	6	6
No Code Available	5	5
Perforation	5	5
Aneurysm	5	5
Stenosis	5	5
Dyspnea	5	5
Thrombosis	5	5
Unspecified Infection	4	4
Ischemia	4	4
Hypoxia	4	4
Embolism	4	4
No Known Impact Or Consequence To Patient	4	4
Discomfort	4	4
Device Embedded In Tissue or Plaque	3	3
Respiratory Insufficiency	3	3
Foreign Body Embolism	3	3
Inflammation	3	3
Pneumothorax	3	3
Foreign Body In Patient	2	2
Injury	2	2
No Patient Involvement	2	2
Cardiac Arrest	2	2
Claudication	2	2
Unspecified Kidney or Urinary Problem	2	2
Calcium Deposits/Calcification	2	2
Pseudoaneurysm	2	2
Hematoma	2	2
Thromboembolism	2	2
Vascular Dissection	2	2
Erosion	2	2
Peritonitis	1	1
Laceration(s) of Esophagus	1	1
Impotence	1	1
Pneumonia	1	1
Bradycardia	1	1
Anemia	1	1
Rupture	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Atrium Medical Corporation	I	May-18-2022