TPLC - Total Product Life Cycle

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Device	catheter introducer kit
Regulation Description	Catheter introducer.
Definition	This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
Product Code	OFC
Regulation Number	870.1340
Device Class	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	16	16
Use of Device Problem	4	4
Material Separation	4	4
Break	3	3
Leak/Splash	2	2
Difficult to Advance	1	1
Material Fragmentation	1	1
Gas/Air Leak	1	1
Material Deformation	1	1
Detachment of Device or Device Component	1	1
Material Too Soft/Flexible	1	1
Improper or Incorrect Procedure or Method	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Thrombosis/Thrombus	13	13
Foreign Body In Patient	7	7
No Clinical Signs, Symptoms or Conditions	4	4
Vascular Dissection	3	3
Insufficient Information	3	3
Pseudoaneurysm	3	3
Ischemia	2	2
Hematoma	2	2
Thromboembolism	2	2
Retroperitoneal Hemorrhage	1	1
Pain	1	1
Perforation of Vessels	1	1