TPLC - Total Product Life Cycle

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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
ANGIOSAFE, INC.
	SUBSTANTIALLY EQUIVALENT	1
AVINGER, INC.
	SUBSTANTIALLY EQUIVALENT	2
BAYLIS MEDICAL TECHNOLOGIES, INC.
	SUBSTANTIALLY EQUIVALENT - KIT	2
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIMFLOW, INC.
	SUBSTANTIALLY EQUIVALENT	2
RA MEDICAL SYSTEMS,INC
	SUBSTANTIALLY EQUIVALENT	2
SOUNDBITE MEDICAL SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	2
TRACTUS VASCULAR, LLC
	SUBSTANTIALLY EQUIVALENT	1
UPSTREAM PERIPHERAL TECHNOLOGIES, LTD.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	368	612
Detachment of Device or Device Component	203	203
Device-Device Incompatibility	64	64
Fracture	56	56
Material Deformation	50	50
Break	46	46
Retraction Problem	44	44
Material Split, Cut or Torn	41	41
Failure to Advance	32	32
Activation Problem	25	25
Material Frayed	22	22
Difficult to Remove	22	22
Peeled/Delaminated	21	21
Entrapment of Device	18	18
Leak/Splash	16	16
Material Twisted/Bent	15	15
Adverse Event Without Identified Device or Use Problem	11	11
Melted	10	10
Material Puncture/Hole	10	10
Improper or Incorrect Procedure or Method	8	8
Flushing Problem	8	8
Noise, Audible	7	7
Sharp Edges	7	7
Problem with Software Installation	7	7
Stretched	6	6
Connection Problem	6	6
Overheating of Device	6	6
Device Dislodged or Dislocated	4	4
Key or Button Unresponsive/not Working	3	3
Difficult to Insert	3	3
Unraveled Material	3	3
Device Contamination with Chemical or Other Material	3	3
Crack	3	3
No Display/Image	3	3
Activation, Positioning or Separation Problem	3	3
Unintended Movement	2	2
Difficult to Advance	2	2
Deformation Due to Compressive Stress	2	2
Therapeutic or Diagnostic Output Failure	1	1
Shipping Damage or Problem	1	1
Visual Prompts will not Clear	1	1
Unintended Ejection	1	1
Defective Device	1	1
Insufficient Information	1	1
Poor Quality Image	1	1
Device Alarm System	1	1
Accessory Incompatible	1	1
Partial Blockage	1	1
Failure to Unfold or Unwrap	1	1
Failure to Fire	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	663	907
Foreign Body In Patient	27	27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
Vascular Dissection	5	5
Insufficient Information	5	5
Perforation of Vessels	5	5
Perforation	4	4
No Patient Involvement	3	3
Pericardial Effusion	2	2
No Consequences Or Impact To Patient	2	2
Hemothorax	2	2
Device Embedded In Tissue or Plaque	2	2
Anemia	1	1
Obstruction/Occlusion	1	1
Thrombosis/Thrombus	1	1
Laceration(s)	1	1
Calcium Deposits/Calcification	1	1
Pseudoaneurysm	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Bard Peripheral Vascular Inc	II	Jan-05-2024