HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR
Received Oct 9, 2019 · Event occurred Aug 31, 2019
Report 2242352-2019-01110 · MDR key 9173731
Device
Generic name
Graft, Vascular, Synthetic/biologic Composite
Manufacturer
Intervascular SasModel number
M00202175926P0Catalog number
M00202175926P0
Lot number
18L07
Product problems
- Manufacturing, Packaging or Shipping Problem
- Manufacturing, Packaging or Shipping Problem
Patient
Not reported
- Blood Loss
- Blood Loss
Narrative
Additional Manufacturer Narrative
TRACKWISE ID # (B)(4). THE DEVICE IS MANUFACTURED BY INTERVASCULAR (B)(4). (B)(4) IS THE IMPORTER OF THE DEVICE. A FOLLOW UP IMPORTER MEDICAL DEVICE REPORT WILL BE SUBMITTED ONCE THE RESULTS FROM THE MANUFACTURER ARE AVAILABLE.
Description of Event or Problem
THE DOCTOR DID THE OPERATION ON (B)(6) 2019. DURING THE OPERATION, THEY USED ONE HEMASHIELD 4B GRAFT AND FOUND THE CONNECTION BETWEEN THE GRAFT BODY AND THESE THREE BRANCHES WAS BLEEDING A LOT. AND THEN THEY USED THE AUTOLOGOUS PERICARDIUM TO MEND THE BLEEDING SITE. IT TOOK AROUND 15 HOURS TO DO THIS OPERATION BECAUSE OF THE BLEEDING ISSUE AND THEREFORE THEY DELAYED STERNAL CLOSURE FOR THE EDEMA.