TPLC - Total Product Life Cycle

• Device: port & catheter, implanted, subcutaneous, intravascular
• Regulation Description: Subcutaneous, implanted, intravascular infusion port and catheter.
• Product Code: LJT
• Regulation Number: 880.5965
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
AESCULAP
	SUBSTANTIALLY EQUIVALENT	1
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
ARROW INTL., INC.
	SUBSTANTIALLY EQUIVALENT	9
B. BRAUN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	8
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	22
CLINICAL PLASTIC PRODUCTS SA
	SUBSTANTIALLY EQUIVALENT	1
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	1
GISH BIOMEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
GRANTADLER CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
HDC CORP.
	SUBSTANTIALLY EQUIVALENT	3
HORIZON MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	6
	SUBSTANTIALLY EQUIVALENT - KIT	5
LEMAITRE VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	2
MED INSTITUTE, INC.
	SUBSTANTIALLY EQUIVALENT	16
	SUBSTANTIALLY EQUIVALENT - KIT	1
MEDCOMP
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	3
NAVILYST MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
NIPRO CORP
	SUBSTANTIALLY EQUIVALENT	1
NORFOLK MEDICAL
	SUBSTANTIALLY EQUIVALENT	16
PFM MEDICAL, INC
	SUBSTANTIALLY EQUIVALENT	3
RITA MEDICAL SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
SMITHS
	SUBSTANTIALLY EQUIVALENT	15
STD MED, INC.
	SUBSTANTIALLY EQUIVALENT	2
TRISTATE
	SUBSTANTIALLY EQUIVALENT - KIT	1
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Fracture	58
Break	18
Leak	12
Suction issue	11
Explanted	11
Implant, removal of	8
Detachment of device component	8
Failure to separate	8
Migration of device or device component	7
Device inoperable	6
Difficult to remove	5
Material fragmentation	4
Device, removal of (non-implant)	4
Port leak(s)	3
Device, or device fragments remain in patient	3
Device Issue	3
Hole in material	3
Tears, rips, holes in device, device material	3
Defective item	3
Difficult to flush	3
Source, detachment from	3
Obstruction within device	2
Crack	2
Degraded	2
Unknown (for use when the device problem is not known)	2
Disconnection	2
Occlusion within device	2
Unraveled material	2
Malfunction	2
Kinked	2
Material separation	2
Decoupling	2
Failure to infuse	2
Defective component	1
Material integrity issue	1
Device maintenance issue	1
Dislodged	1
Improper or incorrect procedure or method	1
Runaway	1
Device clogged	1
Device remains implanted	1
Catheter withdrawal interference	1
Inflation issue	1
Reaction	1
Malposition of device	1
Entrapment of device or device component	1
Replace	1
Implant, repositioning of	1
Device or device fragments location unknown	1
Failure to deliver	1
Failure to flush	1
Stretched	1
Slippage of device or device component	1
Use of Device Issue	1
Retraction problem	1
Disassembly	1
Deployment issue	1
No Information	1
Component(s), broken	1
Difficult to position	1
Total Device Problems	235

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	1	1	0	0
Class II	3	1	2	2	2	2	0
Class III	0	0	0	0	0	1	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Angiodynamics, INC	II	Aug-24-2011
2	Angiodynamics, INC	II	Sep-01-2009
3	B. Braun Interventional Systems	II	Jun-27-2011
4	B. Braun Interventional Systems	II	Sep-03-2009
5	Bard Access Systems	III	Mar-01-2012
6	Bard Access Systems	II	Apr-29-2010
7	Boston Scientific Corp	II	Apr-14-2007
8	Boston Scientific Corp	II	Mar-15-2007
9	Cook Vascular Inc.	II	Sep-17-2008
10	Cook, Inc.	I	Feb-23-2011
11	Medical Components, Inc dba MedComp	II	Jun-26-2012
12	Medical Components, Inc dba MedComp	II	May-18-2012
13	Medical Components, Inc dba MedComp	II	Aug-17-2010
14	Navilyst Medical, Inc	I	Jul-01-2010
15	Rita Medical Systems, Inc.	II	Dec-28-2007