DeathMAL
MAQUET - AXILLO-BIFEMORAL HEMOGARD KNITTED
Received Aug 9, 2023 · Event occurred Jul 21, 2023
Report MW5122781 · MDR key 17490568
Device
Generic name
Graft, Vascular, Synthetic/biologic Composite
Manufacturer
Maquet" Gentinge Group / Intervascular, SasModel number
WATER PERM <5ML/CM2/MINLot number
22K06
Patient
58 YR · Female
- Exsanguination
- Exsanguination
Narrative
Description of Event or Problem
UNDERWENT HEART CAUTERIZATION FOR POSSIBLE INTERVENTION AND INSERTION OF IMPELLA AND ECMO DUE TO CARDIOGENIC SHOCK. DURING INSERTION OF BIFEMORAL GRAPH VIA CUTDOWN TO LEFT ARTERY, UNCONTROLLED BLEEDING. BLEEDING AT GRAPH SITE DESCRIBED AS "SPRAYING/ APPEARING AS A SPRINKLER". ESTIMATED BLOOD LOSS >4L. UNABLE TO CONTROL BLEEDING, PATIENT EXPIRED. THERAPEUTIC RANGE FOR HEPARIN.