TPLC - Total Product Life Cycle

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Premarket Reviews
Manufacturer	Decision
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.)
	SUBSTANTIALLY EQUIVALENT	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	389	2221
Break	81	937
Packaging Problem	31	31
Material Separation	24	24
Mechanical Problem	9	743
Material Integrity Problem	3	3
Physical Resistance/Sticking	2	2
Device Damaged by Another Device	2	2
Product Quality Problem	2	2
Device Slipped	1	1
Device Contaminated During Manufacture or Shipping	1	1
Entrapment of Device	1	1
Accessory Incompatible	1	1
Contamination	1	1
Use of Device Problem	1	1
Delivered as Unsterile Product	1	1
Retraction Problem	1	1
Tear, Rip or Hole in Device Packaging	1	1
Detachment of Device or Device Component	1	1
Mechanical Jam	1	123

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Device Embedded In Tissue or Plaque	214	1800
Cardiac Perforation	210	1064
Pericardial Effusion	156	401
No Clinical Signs, Symptoms or Conditions	80	1178
Perforation of Vessels	29	29
Great Vessel Perforation	25	25
Cardiac Tamponade	13	13
Iatrogenic Source	13	257
Low Blood Pressure/ Hypotension	11	13
Foreign Body In Patient	3	4
Pleural Effusion	3	3
Atrial Perforation	3	3
Tricuspid Valve Insufficiency/ Regurgitation	2	2
Pericarditis	2	2
Laceration(s)	2	2
Hemorrhage/Bleeding	2	2
Pulmonary Embolism	2	2
Perforation	1	1
Atrial Fibrillation	1	1
Obstruction/Occlusion	1	2
No Known Impact Or Consequence To Patient	1	1
Pain	1	1
Hemothorax	1	1
Internal Organ Perforation	1	1