TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ATRAVERSE MEDICAL
	SUBSTANTIALLY EQUIVALENT	2
ATRAVERSE MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
BAYLIS MEDICAL COMPANY
	SUBSTANTIALLY EQUIVALENT	1
CIRCA SCIENTIFIC, INC.
	SUBSTANTIALLY EQUIVALENT	3
COOK INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
CROSS VASCULAR, INC.
	SUBSTANTIALLY EQUIVALENT	1
EDWARDS LIFESCIENCES, LLC
	SUBSTANTIALLY EQUIVALENT	1
ELECTROWIRE MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
NUMED, INC.
	SUBSTANTIALLY EQUIVALENT	1
PRESSURE PRODUCTS MEDICAL DEVICE MANUFACTURING, LLC
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	982	988
Difficult to Advance	231	231
Failure to Advance	222	222
Material Integrity Problem	181	181
Display or Visual Feedback Problem	107	108
Positioning Problem	97	98
Material Deformation	79	79
Physical Resistance/Sticking	71	71
Use of Device Problem	69	69
Device Sensing Problem	53	53
Detachment of Device or Device Component	41	41
Off-Label Use	40	40
Nonstandard Device	31	31
Device-Device Incompatibility	29	29
Difficult to Remove	25	25
Deformation Due to Compressive Stress	23	23
Defective Device	21	21
Device Dislodged or Dislocated	17	17
Material Frayed	16	16
Thermal Decomposition of Device	16	16
Difficult to Insert	16	16
Burst Container or Vessel	15	15
Contamination	15	15
Insufficient Device Problem Information	15	15
Packaging Problem	10	10
Failure to Deliver Energy	9	9
Tear, Rip or Hole in Device Packaging	9	9
Device Displays Incorrect Message	8	8
Unsealed Device Packaging	8	8
Difficult to Open or Remove Packaging Material	6	6
Mechanics Altered	6	6
Delivered as Unsterile Product	4	4
Obstruction of Flow	4	4
Break	4	4
Difficult or Delayed Positioning	3	3
Material Rupture	3	3
High impedance	3	3
Fracture	3	3
Human-Device Interface Problem	3	3
Device Contaminated During Manufacture or Shipping	3	3
Leak/Splash	3	3
Improper Flow or Infusion	2	2
Positioning Failure	2	2
Material Fragmentation	2	2
Unintended Movement	2	2
Patient-Device Incompatibility	2	2
Device Markings/Labelling Problem	2	2
Device Contamination with Chemical or Other Material	2	2
Intermittent Communication Failure	2	2
Component Missing	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pericardial Effusion	963	965
No Clinical Signs, Symptoms or Conditions	585	585
Low Blood Pressure/ Hypotension	472	473
Cardiac Tamponade	379	380
Cardiac Perforation	312	312
Thrombosis/Thrombus	120	122
Perforation of Vessels	92	92
Hematoma	71	71
Cardiac Arrest	67	67
Hemorrhage/Blood Loss/Bleeding	52	52
Perforation	52	55
Tachycardia	42	42
Arrhythmia	34	34
Bradycardia	27	27
Stroke/CVA	24	24
Chest Pain	24	24
Non specific EKG/ECG Changes	22	22
Air Embolism	19	19
Asystole	18	18
Pleural Effusion	17	17
Vascular Dissection	17	17
High Blood Pressure/ Hypertension	16	16
Heart Block	16	16
No Consequences Or Impact To Patient	15	15
Dyspnea	12	12
Atrial Fibrillation	11	11
Swelling/ Edema	10	10
Unspecified Tissue Injury	10	10
Foreign Body In Patient	10	10
Hypoxia	9	9
Ischemia Stroke	9	9
Ventricular Fibrillation	9	9
Hemothorax	8	8
Death	7	7
Fistula	7	7
Pain	6	6
Heart Failure/Congestive Heart Failure	5	5
Embolism/Embolus	5	5
Insufficient Information	5	5
Retroperitoneal Hemorrhage	5	5
Respiratory Arrest	5	5
Hypersensitivity/Allergic reaction	4	4
Pseudoaneurysm	4	4
Respiratory Failure	4	4
No Known Impact Or Consequence To Patient	4	4
Pericarditis	4	4
Loss of consciousness	4	4
Shock	3	3
Renal Failure	3	3
Speech Disorder	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	II	Jul-10-2025
2	Edwards Lifesciences, LLC	I	Apr-25-2019
3	Medtronic Vascular	I	Oct-16-2020