Device Problems
Structural Problem (2506); Deformation Due to Compressive Stress (2889)
Patient Problem
Fistula (1862)
Event Date 01/01/2020
Event Type
Injury
Event Description
(1/2 reference (b)(4) for all related complaints).Smj#cfff107.During the use of the product (a tube), brachiocephalic artery fistula occurred in the patient.The customer suspected that something was wrong with the length and the angle of the product.Therefore, they switched it to competitor's ones.The affected item is either 100/860, 100/811, or 100/800.