TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ABBOTT MEDICAL
	SUBSTANTIALLY EQUIVALENT	1
ACUTUS MEDICAL, INC.
	SUBSTANTIALLY EQUIVALENT	2
BOSTON SCIENTIFIC CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
1. K223824 POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS315 ...
2. K233248 FARADRIVE™ Steerable Sheath
KARDIUM INC.
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC CRYOCATH LP
	SUBSTANTIALLY EQUIVALENT	1
MEDTRONIC INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	2595	2634
Air/Gas in Device	2403	2403
Leak/Splash	1780	1780
Material Twisted/Bent	507	507
Material Integrity Problem	442	442
Gas/Air Leak	391	391
Device Contamination with Body Fluid	331	331
Difficult to Advance	165	165
Deformation Due to Compressive Stress	156	156
Break	123	123
Suction Problem	108	108
Failure to Advance	104	104
Difficult to Insert	101	101
Compatibility Problem	96	96
Unintended Movement	90	90
Positioning Failure	89	89
Difficult to Remove	78	78
Material Split, Cut or Torn	77	77
Material Deformation	71	71
Difficult to Flush	67	67
Improper or Incorrect Procedure or Method	66	66
Use of Device Problem	64	64
Fluid/Blood Leak	62	62
Crack	61	61
Device-Device Incompatibility	55	55
Difficult or Delayed Positioning	51	51
Device Contamination with Chemical or Other Material	48	48
Device Handling Problem	41	41
Off-Label Use	38	38
Physical Resistance/Sticking	34	34
Mechanical Problem	33	33
Peeled/Delaminated	31	31
Detachment of Device or Device Component	31	31
Noise, Audible	30	30
Positioning Problem	28	28
Product Quality Problem	28	28
Unstable	27	27
Material Separation	25	25
Improper Flow or Infusion	20	20
Entrapment of Device	16	16
Material Perforation	14	14
Tear, Rip or Hole in Device Packaging	13	13
Packaging Problem	11	11
No Apparent Adverse Event	10	10
Flushing Problem	9	9
Insufficient Information	9	9
Mechanical Jam	9	9
Signal Artifact/Noise	9	9
Appropriate Term/Code Not Available	8	8
Device Dislodged or Dislocated	8	8

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	5314	5314
Pericardial Effusion	561	561
Low Blood Pressure/ Hypotension	549	549
Perforation	443	482
Cardiac Tamponade	379	379
Thrombosis/Thrombus	291	291
Air Embolism	279	279
Non specific EKG/ECG Changes	238	238
Hemorrhage/Bleeding	215	215
No Consequences Or Impact To Patient	180	180
Cardiac Perforation	146	146
Hematoma	143	143
Atrial Perforation	133	133
Stroke/CVA	118	118
Cardiac Arrest	116	116
Pseudoaneurysm	86	86
No Patient Involvement	80	80
No Known Impact Or Consequence To Patient	79	79
Fistula	76	76
Hypoxia	73	73
Unspecified Tissue Injury	71	71
Perforation of Vessels	68	68
Tachycardia	60	60
Arrhythmia	52	52
Thrombosis	49	49
Bradycardia	46	46
Insufficient Information	45	45
Embolism/Embolus	38	38
Cardiovascular Insufficiency	37	37
Vascular Dissection	30	30
Ventricular Fibrillation	28	28
Dyspnea	27	27
Pain	27	27
Heart Failure/Congestive Heart Failure	27	27
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	26	26
Chest Pain	26	26
Transient Ischemic Attack	24	24
Myocardial Infarction	24	24
Heart Block	23	23
Atrial Fibrillation	22	22
Atrial Flutter	21	21
High Blood Pressure/ Hypertension	18	18
ST Segment Elevation	18	18
Death	17	17
Inflammation	16	16
Paralysis	16	16
Embolism	16	16
Syncope/Fainting	14	14
Muscle Weakness	14	14
Ischemia Stroke	14	14

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	I	Mar-26-2024
2	Medtronic Perfusion Systems	II	Sep-22-2021