FDA.reportPublic FDA data

MAUDE MDR 2798829

MDR report key
2798829
Report number
1219930-2012-00841
Event key
0
Event type
3
Date of event
2012-07-17
Date received
2012-10-12
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
MELISSA ZAFFIN
Address
60 MIDDLETOWN AVENUE NORTH HAVEN CT 06473 US
Phone
203-203-2034
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1VASCUFIL 7/0 30 D/A BLUE CV-1NON-ABSORBABLE SUTURING PRODUCTCOVIDIEN LP, FORMERLY US SURGICALGAS8886470401VA1K0297XR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-10-1201. O; 2. R

Event Narratives#

D

Patient 1

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.

N

Patient 1

(B)(4).