GELSOFT
Received Mar 14, 2019 · Event occurred Feb 13, 2019
Report 9612515-2019-00003 · MDR key 8419600
Device
Generic name
Gelsoft Gelatin Impregnated Knitted Vascular Prosthesis
Manufacturer
Vascutek Ltd.Model number
GELSOFT BIFURCATECatalog number
631608-G
Lot number
17601138-1664
Product problems
- Material Puncture/Hole
- Material Perforation
- Material Integrity Problem
- Material Puncture/Hole
- Material Perforation
- Material Integrity Problem
Patient
58 YR
- Blood Loss
- Blood Loss
Narrative
Additional Manufacturer Narrative
(B)(4). THIS REPORT IS BEING SUBMITTED AS AN INITIAL / FINAL REPORT. AS NO DEVICE IS BEING RETURNED FOR FURTHER INVESTIGATION, VASCUTEK LTD. NOW CONSIDERS THIS COMPLAINT CLOSED HOWEVER, THE ISSUE WILL BE TRACKED AND TRENDED AS PART OF THE ON-GOING COMPLAINTS TRENDING AND REPORTING PROCESS AND IF AN ADVERSE TREND DEVELOPS ACTION MAY BE TAKEN AT THAT TIME.
Description of Event or Problem
EVENT WAS REPORTED TO VASCUTEK LTD. AS FOLLOWS: "AFTER BLOOD FLOW RELEASE THE GRAFT SHOWED A LEAKAGE AT THE SIGHT OF THE BIFURCATE JUNCTION. THE SURGEON APPLIED A FEW STITCHES TO STOP THE BLEEDING".