TPLC - Total Product Life Cycle

• Device: tube, drainage, suprapubic
• Regulation Description: Suprapubic urological catheter and accessories.
• Product Code: FFA
• Regulation Number: 876.5090
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Break	37
Difficult to remove	29
Foreign material present in device	14
Tear, rip or hole in device packaging	13
Fracture	7
Device, or device fragments remain in patient	6
Sticking	6
Unsealed device packaging	5
Kinked	5
Component(s), broken	4
Detachment of device component	4
Bent	4
Device damaged prior to use	4
Failure to advance	3
Difficult to position	3
Peeled	2
Material separation	2
Tip breakage	2
Calcified	2
Difficult to deploy	2
Dislodged	2
Leak	2
Migration of device or device component	2
Split	2
Defective item	2
Detachment of device or device component	2
Difficult to open or remove packaging material	2
Dislodged or dislocated	2
Torn material	2
Device Issue	2
Unintended movement	1
Material deformation	1
No Known Device Problem	1
Packaging issue	1
Positioning Issue	1
Difficult to advance	1
Device or device fragments location unknown	1
Catheter withdrawal interference	1
Malposition of device	1
Delivery system failure	1
Physical resistance	1
Defective component	1
Failure to deliver	1
Wire(s), breakage of	1
Occlusion within device	1
Melted	1
Knotted	1
Hole in material	1
Entrapment of device or device component	1
Foreign material	1
Material disintegration	1
Degraded	1
Twisting	1
Uncoiled	1
Use of Device Issue	1
Material perforation	1
Tears, rips, holes in device, device material	1
Shaft break	1
Shipping damage or problem	1
Sterility	1
Regenerate	1
Total Device Problems	205

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

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	May-21-2009