TPLC - Total Product Life Cycle

Device	catheter for crossing total occlusions
Regulation Description	Percutaneous catheter.
Definition	To facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including subchronic and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, such as angioplasty, atherectomy or stent placement.
Product Code	PDU
Regulation Number	870.1250
Device Class	2

Premarket Reviews
Manufacturer	Decision
BAYLIS MEDICAL CO., INC.
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC CORP.
	SUBSTANTIALLY EQUIVALENT	2
BRIDGEPOINT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
CORDIS CORP.
	SUBSTANTIALLY EQUIVALENT	4
FLOWCARDIA, INC.
	SUBSTANTIALLY EQUIVALENT	3
INTRALUMINAL THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	2
MEDTRONIC, INC.
	SUBSTANTIALLY EQUIVALENT	3
RA MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
REVASCULAR THERAPEUTICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPECTRANETICS CORP.
	SUBSTANTIALLY EQUIVALENT	7

Device Problems
Material separation	60
Detachment of device or device component	32
Fracture	25
Retraction problem	21
Device-device incompatibility	12
Torn material	9
Device inoperable	7
Difficult to remove	5
Overheating of device or device component	5
Break	5
Kinked	4
Noise, Audible	4
Material twisted	4
Difficult or delayed activation	4
Material deformation	3
No Known Device Problem	3
Failure to advance	3
Difficult to advance	2
Dislodged or dislocated	2
Material frayed	2
Detachment of device component	2
Difficult to deploy	2
Entrapment of device or device component	2
Unraveled material	2
Use of Device Issue	2
Difficult to position	1
Material puncture	1
Crack	1
Leak	1
Foreign material present in device	1
Connection issue	1
Deployment issue	1
Device or device component damaged by another device	1
Positioning Issue	1
Material integrity issue	1
Mechanical jam	1
Total Device Problems	233

Recalls
Manufacturer		Recall Class	Date Posted
1	Volcano Corporation	II	Sep-02-2015