TPLC - Total Product Life Cycle

• Device: introducer, catheter
• Regulation Description: Catheter introducer.
• Product Code: DYB
• Regulation Number: 870.1340
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ABBOTT
	SUBSTANTIALLY EQUIVALENT	1
ACUMEN, INC.
	SUBSTANTIALLY EQUIVALENT	9
ADVANCED CARDIOVASCULAR SYSTEMS
	SUBSTANTIALLY EQUIVALENT	4
ANGEION CORP.
	SUBSTANTIALLY EQUIVALENT	3
ANGIODYNAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
APPLIED MEDICAL RESOURCES CORP.
	SUBSTANTIALLY EQUIVALENT	4
ARROW INTL., INC.
	SUBSTANTIALLY EQUIVALENT	11
ARSTASIS, INC.
	SUBSTANTIALLY EQUIVALENT	8
B. BRAUN MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	9
BAXTER HEALTHCARE CORP.
	SUBSTANTIALLY EQUIVALENT	2
BAYLIS MEDICAL CO., INC.
	SUBSTANTIALLY EQUIVALENT	2
BD
	SUBSTANTIALLY EQUIVALENT	1
BIOSENSE
	SUBSTANTIALLY EQUIVALENT	1
BIPORE, INC.
	SUBSTANTIALLY EQUIVALENT	3
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	8
	SUBSTANTIALLY EQUIVALENT - KIT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	12
CONTRACT MANUFACTURER
	SUBSTANTIALLY EQUIVALENT	1
COOK, INC.
	SUBSTANTIALLY EQUIVALENT	5
CORDIS CORP.
	SUBSTANTIALLY EQUIVALENT	19
CRYOCOR, INC.
	SUBSTANTIALLY EQUIVALENT	1
DATASCOPE CORP.
	SUBSTANTIALLY EQUIVALENT	5
DIAG CORP.
	SUBSTANTIALLY EQUIVALENT	2
EDWARDS LIFESCIENCES
	SUBSTANTIALLY EQUIVALENT	5
ENDOLOGIX, INC.
	SUBSTANTIALLY EQUIVALENT	3
ENPATH MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	4
EP MEDSYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
E-Z-EM, INC.
	SUBSTANTIALLY EQUIVALENT	1
FOOTPRINT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
GALT MEDICAL CORP.
	SUBSTANTIALLY EQUIVALENT	2
GUIDANT CORP
	SUBSTANTIALLY EQUIVALENT	2
GUIDED DELIVERY SYSTEMS
	SUBSTANTIALLY EQUIVALENT	1
HDC CORP.
	SUBSTANTIALLY EQUIVALENT	2
HEARTPORT, INC.
	SUBSTANTIALLY EQUIVALENT	1
HORIZON MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
INTERMEDICS
	SUBSTANTIALLY EQUIVALENT	1
JOHNSON & JOHNSON
	SUBSTANTIALLY EQUIVALENT	1
KENDALL
	SUBSTANTIALLY EQUIVALENT	3
MALLINCKRODT
	SUBSTANTIALLY EQUIVALENT	2
MARTECH MEDICAL PRODUCTS
	SUBSTANTIALLY EQUIVALENT	2
MAXXIM MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
MEADOX
	SUBSTANTIALLY EQUIVALENT	1
MEDCOMP
	SUBSTANTIALLY EQUIVALENT	4
MEDICAL DEVICE TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	5
MERIT MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	4
MICRO THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
MICROVENA
	SUBSTANTIALLY EQUIVALENT	1
MICRUS
	SUBSTANTIALLY EQUIVALENT	1
NMT CORP.
	SUBSTANTIALLY EQUIVALENT	1
NOVOSTE CORP
	SUBSTANTIALLY EQUIVALENT	1
OHMEDA MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
OSCOR, INC.
	SUBSTANTIALLY EQUIVALENT	8
PACE MEDICAL INC.
	SUBSTANTIALLY EQUIVALENT	1
PAJUNK GMBH
	SUBSTANTIALLY EQUIVALENT	1
Remington Medical, Inc.
	SUBSTANTIALLY EQUIVALENT	1
SCHNEIDER/NAMIC
	SUBSTANTIALLY EQUIVALENT	1
	SUBSTANTIALLY EQUIVALENT - KIT	1
SMITHS
	SUBSTANTIALLY EQUIVALENT	1
SPECIALIZED HEALTH PRODUCTS
	SUBSTANTIALLY EQUIVALENT	1
ST. JUDE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	39
TELECTRONICS
	SUBSTANTIALLY EQUIVALENT	1
TELEFLEX MEDICAL
	SUBSTANTIALLY EQUIVALENT	8
TERUMO CARDIOVASCULAR SYSTEMS
	SUBSTANTIALLY EQUIVALENT	20
TFX MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
THOMAS MEDICAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	17
THORATEC CORP.
	SUBSTANTIALLY EQUIVALENT	1
TOGO MEDIKIT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	2
UNITED STATES SURGICAL
	SUBSTANTIALLY EQUIVALENT	3
USCI ANGIOGRAPHY DIVISION
	SUBSTANTIALLY EQUIVALENT	3
VASCULAR SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	1
VYGON CORP.
	SUBSTANTIALLY EQUIVALENT	2
W.L. GORE & ASSOCIATES,INC
	SUBSTANTIALLY EQUIVALENT	6

Device Problems
Material separation	260
Break	209
No Known Device Problem	175
Leak	174
Other (for use when an appropriate device code cannot be identified)	128
Detachment of device component	100
Use of Device Issue	53
Disconnection	39
Fluid leak	36
Unraveled material	34
Difficult to remove	30
Device, or device fragments remain in patient	23
Material frayed	23
Unknown (for use when the device problem is not known)	23
Air leak	22
Tears, rips, holes in device, device material	21
Difficult to insert	21
Crack	20
Fracture	20
Decoupling	17
Device, removal of (non-implant)	15
Material perforation	15
Component(s), broken	14
Kinked	14
Reaction	14
Physical resistance	14
Blockage within device or device component	13
Contamination during use	12
Packaging issue	12
Scratched material	10
Tip breakage	10
Unsealed device packaging	9
Detachment of device or device component	9
Material rupture	8
Foreign material present in device	8
Difficult to advance	7
Source, detachment from	7
No code available	7
Stretched	6
Material integrity issue	6
Hole in material	6
Device operates differently than expected	6
Dislodged	5
Failure to advance	4
Wire(s), breakage of	4
Device Issue	4
Material fragmentation	4
Migration of device or device component	4
No Information	4
Delivered as unsterile product	4
Occlusion within device	3
Bleed back	3
Torn material	3
Device or device fragments location unknown	3
Split	3
Foreign material	3
Device remains implanted	3
Sterility	3
Device operational issue	3
Device or device component damaged by another device	3
Tear, rip or hole in device packaging	3
Material deformation	3
Device-device incompatibility	3
Improper or incorrect procedure or method	3
Fitting problem	2
Valve(s), failure of	2
Product quality issue	2
Human-Device Interface Issue	2
Infusion or flow issue	2
Incomplete or missing packaging	2
Uncoiled	2
Inflation issue	2
Component incompatible	2
Bent	2
Deployment issue	2
Not Applicable	2
Temperature issue	2
Mechanical issue	2
Melted	2
Dissection	2
Electrode(s), migration of	2
Explanted	2
Difficult to deploy	2
Failure to pace or properly pace	2
Device damaged prior to use	2
Valve(s), defective	2
Blood pooling	1
Malfunction	1
High Readings	1
Invalid sensing	1
Failure to shock or properly shock	1
Component falling	1
Entrapment of device or device component	1
Connection error	1
Collapse	1
Device abrasion from instrument or another object	1
Mislabeled	1
Material puncture	1
Retraction problem	1
Slippage of device or device component	1
Total Device Problems	1783

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	2	5	2	0	0
Class II	4	5	5	3	4	3	1
Class III	0	0	0	0	0	1	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Abbott Vascular, Inc.	II	Mar-08-2007
2	Angiodynamics, INC	II	Oct-13-2011
3	Arrow International Inc	II	Jan-21-2011
4	Arrow International Inc	II	Sep-25-2010
5	Arrow International Inc	I	Mar-05-2010
6	Arrow International Inc	II	Jun-24-2009
7	Arstasis, Inc	I	Feb-04-2011
8	Bard Access Systems	II	Mar-06-2013
9	Baylis Medical Corp *	I	Mar-10-2010
10	Biosense Webster, Inc.	II	Feb-28-2007
11	Boston Scientific Corp	II	Apr-09-2009
12	Boston Scientific Corp	II	Dec-07-2007
13	C. R.Bard, Inc./BardElectrophysiology Division	II	Nov-07-2008
14	Cook, Inc.	II	Apr-16-2008
15	Cordis Corporation	II	Apr-20-2010
16	Cordis Corporation	I	Nov-05-2009
17	Edwards Lifesciences, Llc	II	Aug-25-2009
18	Greatbatch Medical	II	Dec-22-2012
19	Greatbatch Medical	II	Oct-24-2012
20	Greatbatch Medical	II	Aug-27-2010
21	Medtronic, Inc.	II	Dec-02-2008
22	Merit Medical Systems, Inc.	I	Jan-28-2011
23	Merit Medical Systems, Inc.	II	Dec-14-2009
24	Merit Medical Systems, Inc.	II	Jun-10-2009
25	Oscor, Inc.	II	Oct-29-2008
26	St Jude Medical Inc	III	Dec-28-2012
27	St. Jude Medical / Daig Division	II	Mar-01-2007
28	St. Jude Medical Cardiovascular Division	I	Aug-12-2010
29	Terumo Medical Corporation	II	Jun-06-2011
30	Thomas Medical Products Inc	II	Jan-11-2012
31	Thomas Medical Products Inc	II	Feb-14-2011
32	Thomas Medical Products Inc	I	Mar-04-2010
33	Thomas Medical Products Inc	I	Feb-02-2010
34	Thomas Medical Products Inc	I	Nov-24-2009
35	Thomas Medical Products Inc	II	Nov-03-2008