VASCUFIL 7/0 30 D/A BLUE CV-1
Received Oct 12, 2012 · Event occurred Jul 17, 2012
Report 1219930-2012-00841 · MDR key 2798829
Device
Generic name
Non-absorbable Suturing Product
Manufacturer
Covidien Lp, Formerly Us SurgicalCatalog number
8886470401V
Lot number
A1K0297X
Product problems
- Break
- Material Fragmentation
Patient
81 YR
- Hematoma
- Hemorrhage/Blood Loss/Bleeding
Narrative
Description of Event or Problem
PROCEDURE: ARTERIOTOMY SUTURE OF INTERNAL COMMON CAROTID. ACCORDING TO THE REPORTER: THE SUTURE BROKE AT HALF SUTURE. THE SUTURE WAS STARTED AGAIN WITH A NEW VASCUFIL 7/0, SAME LOT NUMBER, STARTING FROM THE DISTAL POINT OF ARTERIOTOMY WITH CONTINUE SUTURE, UP TO KNOTTING THIS NEW THREAD WITH THE END OF PREVIOUS ONE. THEN, IT WAS PERFORMED A REINFORCEMENT OF THE FIRST SUTURE WITH THE SECOND ONE. WHEN PATIENT WAS EXTUBATED, A SUDDEN RIGHT LATERO-CERVICAL HAEMATOMA APPEARED. PATIENT WAS CANNULIZED IN EMERGENCY AND, MEANWHILE, THE HAEMATOMA EMPTYING WAS PERFORMED. AFTER THE EMERGENCY OPERATIONS TO STOP BLEEDING BY VESSEL CLAMPING, IT WAS FOUND A BREACH (AN OPENING) ON THE SUTURE FROM THE DISTAL END TO THE MIDDLE KNOTTING POINT, WITH AN EVIDENT BREAK OF THREAD. THE FRAGMENT OF THE BROKEN SUTURE WERE REMOVED AND A NEW SUTURE WAS PERFORMED USING THE PRODUCT WITH DIFFERENT LOT NUMBER.
Additional Manufacturer Narrative
(B)(4).