TPLC - Total Product Life Cycle

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Device	catheter for crossing total occlusions
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
AVINGER, INC.
	SUBSTANTIALLY EQUIVALENT	3
BAYLIS MEDICAL TECHNOLOGIES INC.
	SUBSTANTIALLY EQUIVALENT - KIT	1
C.R. BARD, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIMFLOW, INC.
	SUBSTANTIALLY EQUIVALENT	1
RA MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	2
SOUNDBITE MEDICAL SOLUTION INC.
	SUBSTANTIALLY EQUIVALENT	1
SOUNDBITE MEDICAL SOLUTIONS, INC.
	SUBSTANTIALLY EQUIVALENT	2
TRACTUS VASCULAR, LLC
	SUBSTANTIALLY EQUIVALENT	1
UPSTREAM PERIPHERAL TECHNOLOGIES, LTD
	SUBSTANTIALLY EQUIVALENT	1
XABLECATH, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Material Separation	351	595
Detachment of Device or Device Component	176	176
Fracture	67	67
Device-Device Incompatibility	57	57
Retraction Problem	55	55
Material Split, Cut or Torn	49	49
Material Deformation	47	47
Break	43	43
Activation Problem	37	37
Failure to Advance	33	33
Material Twisted/Bent	33	33
Difficult to Remove	26	26
Material Frayed	23	23
Adverse Event Without Identified Device or Use Problem	20	20
Leak/Splash	17	17
Melted	10	10
Noise, Audible	10	10
Material Puncture/Hole	9	9
Overheating of Device	9	9
Stretched	6	6
Flushing Problem	5	5
Difficult to Advance	5	5
Entrapment of Device	5	5
Peeled/Delaminated	4	4
Sharp Edges	4	4
Problem with Software Installation	4	4
Connection Problem	3	3
Device Contamination with Chemical or Other Material	3	3
Unraveled Material	3	3
Difficult to Insert	3	3
Crack	3	3
Deformation Due to Compressive Stress	2	2
Difficult or Delayed Activation	2	2
Improper or Incorrect Procedure or Method	2	2
Activation, Positioning or Separation Problem	2	2
Visual Prompts will not Clear	1	1
Material Fragmentation	1	1
Patient Device Interaction Problem	1	1
Use of Device Problem	1	1
Component Missing	1	1
Off-Label Use	1	1
Structural Problem	1	1
Reflux within Device	1	1
Malposition of Device	1	1
Physical Resistance/Sticking	1	1
Material Integrity Problem	1	1
Migration	1	1
Failure to Unfold or Unwrap	1	1
Therapeutic or Diagnostic Output Failure	1	1
Partial Blockage	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	469	713
No Consequences Or Impact To Patient	122	122
Foreign Body In Patient	18	18
No Patient Involvement	18	18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	13	13
No Known Impact Or Consequence To Patient	11	11
Injury	9	9
Perforation of Vessels	7	7
Vascular Dissection	5	5
Perforation	5	5
Insufficient Information	5	5
Device Embedded In Tissue or Plaque	5	5
No Code Available	2	2
Hematoma	2	2
Fistula	2	2
Vessel Or Plaque, Device Embedded In	1	1
Anemia	1	1
Obstruction/Occlusion	1	1
Blood Loss	1	1
Pericardial Effusion	1	1
Cardiac Tamponade	1	1
Cardiac Perforation	1	1
Thrombosis	1	1
Laceration(s)	1	1
Hemothorax	1	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Bard Peripheral Vascular Inc	II	Jan-05-2024
2	Ra Medical Systems Inc	II	Aug-08-2019
3	Ra Medical Systems, Inc.	II	Dec-14-2020
4	Ra Medical Systems, Inc.	II	Oct-02-2020
5	Ra Medical Systems, Inc.	II	Jul-04-2020
6	Ra Medical Systems, Inc.	II	May-14-2020