8MM 30CM HEMASHIELD PLAT WDV
Received May 28, 2014 · Event occurred May 2, 2014
Report 2242352-2014-00626 · MDR key 3865504
Device
Generic name
Vascular Graft
Manufacturer
Maquet Cardiovascular, LlcModel number
M00202175208P0Lot number
25071735
Product problems
- Leak/Splash
Patient
Not reported
- Blood Loss
Narrative
Description of Event or Problem
THE HOSPITAL REPORTED DURING AN ASCENDING AORTA REPLACEMENT, AN 8 MM 30 CM HEMASHIELD PLAT WDV WAS USED FOR A PERFUSION LINE AND THE HOSPITAL STAFF REPORTED EXCESSIVE BLEEDING FROM THE GRAFT. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. A TRANSFUSION WAS NOT REQUIRED AND THE PATIENT IS RECOVERING. THE GRAFT IS NOT RETURNING.
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 NON-CONFORMANCE RECORDED IN THE LOT HISTORY. THERE ARE NO OTHER SIMILAR COMPLAINTS REPORTED AGAINST THIS BATCH. (B)(4).