TPLC - Total Product Life Cycle

• Device: catheter, septostomy
• Regulation Description: Septostomy catheter.
• Product Code: DXF
• Regulation Number: 870.5175
• Device Class: 2

Premarket Reviews
Manufacturer	Decision
ATRAVERSE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
1.  K240900  HOTWIRE™ RF Guidewire
BAYLIS MEDICAL COMPANY
	SUBSTANTIALLY EQUIVALENT	1
CIRCA SCIENTIFIC, INC.
	SUBSTANTIALLY EQUIVALENT	3
CROSS VASCULAR INC.
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
NUMED, INC.
	SUBSTANTIALLY EQUIVALENT	1

MDR Year	MDR Reports	MDR Events
2020	55	55
2021	39	39
2022	70	70
2023	288	288
2024	368	368
2025	248	248

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	528	528
Failure to Advance	118	118
Difficult to Advance	113	113
Material Integrity Problem	79	79
Display or Visual Feedback Problem	78	78
Positioning Problem	66	66
Material Deformation	54	54
Use of Device Problem	37	37
Physical Resistance/Sticking	35	35
Detachment of Device or Device Component	29	29
Device-Device Incompatibility	19	19
Defective Device	16	16
Difficult to Remove	15	15
Insufficient Information	14	14
Burst Container or Vessel	14	14
Material Frayed	13	13
Thermal Decomposition of Device	12	12
Device Dislodged or Dislocated	11	11
Contamination	9	9
Device Displays Incorrect Message	7	7
Packaging Problem	6	6
Deformation Due to Compressive Stress	5	5
Unsealed Device Packaging	5	5
Difficult to Insert	5	5
Difficult to Open or Remove Packaging Material	4	4
Break	4	4
Material Rupture	4	4
Tear, Rip or Hole in Device Packaging	4	4
Failure to Deliver Energy	3	3
High impedance	3	3
Obstruction of Flow	3	3
Fracture	3	3
Device Contaminated During Manufacture or Shipping	3	3
Leak/Splash	3	3
Device Markings/Labelling Problem	2	2
Unintended Movement	2	2
Positioning Failure	2	2
Difficult or Delayed Positioning	2	2
Device Contamination with Chemical or Other Material	2	2
Output below Specifications	1	1
Improper or Incorrect Procedure or Method	1	1
Difficult to Open or Close	1	1
Appropriate Term/Code Not Available	1	1
No Apparent Adverse Event	1	1
Failure to Fire	1	1
Electromagnetic Compatibility Problem	1	1
Mechanics Altered	1	1
Activation, Positioning or Separation Problem	1	1
Improper Flow or Infusion	1	1
Component Missing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pericardial Effusion	488	488
No Clinical Signs, Symptoms or Conditions	302	302
Low Blood Pressure/ Hypotension	230	230
Cardiac Tamponade	196	196
Cardiac Perforation	157	157
Thrombosis/Thrombus	68	68
Perforation of Vessels	47	47
Hematoma	38	38
Perforation	38	38
Cardiac Arrest	33	33
Hemorrhage/Bleeding	27	27
Arrhythmia	21	21
Tachycardia	18	18
Bradycardia	15	15
Stroke/CVA	13	13
Air Embolism	12	12
Asystole	12	12
No Consequences Or Impact To Patient	10	10
Chest Pain	9	9
Vascular Dissection	8	8
Hemothorax	7	7
Heart Block	7	7
Dyspnea	7	7
Non specific EKG/ECG Changes	6	6
Atrial Fibrillation	6	6
Pleural Effusion	6	6
Ventricular Fibrillation	6	6
High Blood Pressure/ Hypertension	5	5
Fistula	5	5
Insufficient Information	5	5
Foreign Body In Patient	5	5
Death	4	4
Respiratory Arrest	4	4
Pseudoaneurysm	4	4
Hypoxia	4	4
Embolism/Embolus	4	4
Pain	4	4
Thromboembolism	3	3
Swelling/ Edema	3	3
Unspecified Tissue Injury	3	3
Intracranial Hemorrhage	3	3
Burn(s)	3	3
Transient Ischemic Attack	3	3
Diminished Pulse Pressure	3	3
Retroperitoneal Hemorrhage	2	2
Needle Stick/Puncture	2	2
Pericarditis	2	2
Ischemia Stroke	2	2
Heart Failure/Congestive Heart Failure	2	2
Shock	2	2

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Vascular	I	Oct-16-2020