MalfunctionMAL

HEMASHIELD

Received Feb 9, 2022 · Event occurred Jan 18, 2022

Report 13497265 · MDR key 13497265

Device

Generic name

Graft, Vascular, Synthetic/biologic Composite

Manufacturer

Intervascular Sas

Lot number

19F05

Product problems

Therapeutic or Diagnostic Output Failure

Patient

22630 DA · Unknown

Insufficient Information
Insufficient Information

Narrative

Description of Event or Problem

HEMASHIELD GOLD KNITTED MICROVEL STRAIGHT DOUBLE VELOUR VASCULAR GRAFT FAILED WHILE CANNULATING FOR VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO). REPLACED WITH NEW GRAFT.