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
ALVEOLUS, INC
	SE - WITH LIMITATIONS	1
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
ENDOCHOICE, INC.
	SUBSTANTIALLY EQUIVALENT	1
M.I. TECH CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC
	SUBSTANTIALLY EQUIVALENT	1
MERIT MEDICAL SYSTEMS, INC.
	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	312	312
Adverse Event Without Identified Device or Use Problem	121	121
Positioning Problem	118	118
Material Deformation	115	115
Break	110	110
Activation Failure	90	90
Positioning Failure	65	65
Device Dislodged or Dislocated	63	63
Detachment Of Device Component	56	56
Difficult to Remove	54	54
Migration or Expulsion of Device	52	52
Insufficient Information	38	38
Failure to Advance	38	38
Detachment of Device or Device Component	34	34
Fracture	34	34
Leak/Splash	31	31
Migration	30	30
Appropriate Term/Code Not Available	29	29
Material Separation	28	28
Use of Device Problem	25	25
Malposition of Device	25	25
Premature Activation	23	23
Unraveled Material	22	22
Occlusion Within Device	20	20
Device Operates Differently Than Expected	19	19
Material Twisted/Bent	18	18
Device Slipped	18	18
Material Integrity Problem	17	17
Difficult or Delayed Positioning	17	17
Burst Container or Vessel	16	16
Difficult to Advance	16	16
Expiration Date Error	16	16
Material Rupture	16	16
Sticking	15	15
Defective Device	15	15
Physical Resistance	15	15
Obstruction of Flow	15	15
Loose or Intermittent Connection	14	14
Inaccurate Information	12	12
Deflation Problem	10	10
Device-Device Incompatibility	10	10
Bent	10	10
Inflation Problem	9	9
Difficult to Insert	9	9
Mechanical Problem	8	8
Entrapment of Device	8	8
Deformation Due to Compressive Stress	8	8
Human-Device Interface Problem	7	7
Kinked	7	7
Device Stenosis	6	6

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Consequences Or Impact To Patient	545	545
No Clinical Signs, Symptoms or Conditions	265	265
No Known Impact Or Consequence To Patient	128	128
No Information	123	123
No Code Available	41	41
Death	40	40
Hemorrhage/Bleeding	35	35
Occlusion	34	34
Thrombosis	32	32
Blood Loss	29	29
Renal Failure	25	25
Stenosis	24	24
No Patient Involvement	20	20
Obstruction/Occlusion	20	20
Ischemia	14	14
Foreign Body In Patient	13	13
Insufficient Information	13	13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Vascular Dissection	12	12
Hematoma	10	10
Aneurysm	10	10
Dyspnea	10	10
Unspecified Infection	7	7
Device Embedded In Tissue or Plaque	7	7
Inflammation	7	7
Embolism	7	7
Claudication	7	7
Rupture	7	7
Perforation of Vessels	7	7
Restenosis	6	6
Thrombosis/Thrombus	6	6
Stenosis of the esophagus	6	6
Thrombus	6	6
Perforation	6	6
Pneumonia	6	6
Injury	5	5
Pneumothorax	5	5
Cancer	5	5
Hypoxia	5	5
Discomfort	4	4
Tissue Damage	4	4
Hemoptysis	4	4
Myocardial Infarction	4	4
Pseudoaneurysm	4	4
Airway Obstruction	4	4
Complaint, Ill-Defined	4	4
Respiratory Failure	4	4
Fistula	4	4
Pain	3	3
Calcium Deposits/Calcification	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Atrium Medical Corporation	I	May-18-2022
2	Atrium Medical Corporation	II	Jul-07-2017
3	Boston Scientific Corporation	II	Apr-25-2016
4	Boston Scientific Corporation	II	Jul-15-2011
5	Boston Scientific Corporation	II	Aug-31-2010
6	Boston Scientific Corporation	II	Jun-25-2010
7	EXP Pharmaceutical Services Corp	II	Jul-24-2015
8	SPS Sterilization, Inc	II	Sep-13-2018