HEMA 1 BRANCH 26MM PLATINUM GRAFT
Received Jan 30, 2014 · Event occurred Dec 9, 2013
Report 2242352-2014-00039 · MDR key 3611947
Device
Generic name
Vascular Graft
Manufacturer
Maquet Cardiovascular, LlcModel number
M00202175826P0Catalog number
NA
Lot number
25073981
Product problems
- Insufficient Device Problem Information
Patient
59 YR
- Blood Loss
Narrative
Description of Event or Problem
THE HOSPITAL REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR, THERE WAS BLEEDING DURING USE OF THE GRAFT; FROM ONE OF THE BRANCH CONNECTIONS. THE PROCEDURE WAS COMPLETED BY USING SUTURES. THE PT REQUIRED A TRANSFUSION, BUT THE AMOUNT OF BLOOD LOSS WASN'T CHECKED. CURRENTLY, THE PT IS OK.
Additional Manufacturer Narrative
SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR STANDARD SOP'S, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR THE REPORTED PRODUCT LOT NUMBER. THERE WAS NO NONCONFORMANCE RECORDED IN THE LOT HISTORY. (B)(4).